Chrysalis Intelligence · Product Codes · FGB

FGB · Unclassified

56 clearances · 36 unique sponsors

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Device class
—
Regulation —
Total clearances
56
2020-07-24 → 2026-08-14
Last 12 months
11
Unique sponsors
36
Classification details
Medical specialty
—
Review panel
—
Regulation number
—
Implant
—
Life-sustain / support
—
GMP exempt
—
Third-party review
—
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Hunan Vathin Medical Instrument Co., Ltd. 5 0 2025-05-06
Shanghai AnQing Medical Instrument Co., Ltd. 5 1 2025-10-03
Karl Storz SE & CO. KG 4 1 2025-11-18
STERIS Corporation 3 0 2023-07-25
Boston Scientific Corporation 3 1 2025-09-24
Scivita Medical Technology Co., Ltd. 2 1 2026-08-14
MacroLux Medical Technology Co., Ltd. 2 1 2026-07-20
Guangzhou Red Pine Medical Instrument Co., Ltd. 2 1 2025-12-16
Huger Medical Instrument Co., Ltd. 2 0 2024-07-01
Ambu A/S 2 0 2024-08-16
OTU Medical, Inc. 1 0 2021-07-22
Roen Surgical, Inc. 1 1 2026-08-07
Dongguan Zsr Biomedical Technology Company Limited 1 0 2025-02-11
Anhui Happiness Workshop Instruments Co., Ltd. 1 1 2026-04-09
Zhuhai Pusen Medical Technology Co., Ltd. 1 0 2024-07-16
Karl Storz Endovision, Inc. 1 0 2024-06-10
Hunan Endoso Life Technology Co., Ltd. 1 0 2025-01-22
Sg Endoscopy Pte, Ltd. 1 0 2025-05-02
Richard Wolf Medical Instruments Corporation 1 0 2021-01-15
Seplou (Zhuhai) Co., Ltd. 1 0 2025-08-26
Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi 1 0 2024-08-16
Shenzhen Besdata Technology Co., Ltd. 1 0 2024-10-04
Karl Storz Endoscopy America 1 0 2022-01-20
Calyxo, Inc. 1 1 2026-03-06
Auris Health, Inc. 1 0 2022-04-29
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
52353 CPT — High Cystourethroscopy with manipulation of ureteral calculus; ureteroscope used
52356 CPT — High Cystourethroscopy with transurethral resection of bladder tumor via ureteroscope
50957 CPT — Medium Ureteral endoscopy through existing ureterostomy
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-08-14 K262552 Scivita Medical Technology Co., Ltd. Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)
2026-08-07 K253505 Roen Surgical, Inc. Zamenix™ P
2026-07-20 K260516 MacroLux Medical Technology Co., Ltd. BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)
2026-04-09 K252929 Anhui Happiness Workshop Instruments Co., Ltd. Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)
2026-03-06 K260013 Calyxo, Inc. CVAC Image Processor
2025-12-16 K252468 Zhejiang Geyi Medical Instrument Co., Ltd. Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)
2025-12-16 K251951 Guangzhou Red Pine Medical Instrument Co., Ltd. Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F)
2025-11-18 K253411 Karl Storz SE & CO. KG Miniature Telescope for Urology (27033AA)
2025-10-31 K250917 Shenzhen Sanping Image Technology Co., Ltd. Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8)
2025-10-03 K252806 Shanghai AnQing Medical Instrument Co., Ltd. Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)
2025-09-24 K252703 Boston Scientific Corporation LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)
2025-08-26 K250049 Seplou (Zhuhai) Co., Ltd. Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000)
2025-06-06 K243550 Karl Storz SE & CO. KG KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)
2025-05-28 K242699 Opcom Medical, Inc. Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12)
2025-05-06 K250785 Hunan Vathin Medical Instrument Co., Ltd. Single-use Flexible Ureteroscope
2025-05-02 K243894 Sg Endoscopy Pte, Ltd. F88 URE-SD/RD Flexible Ureteroscope
2025-04-28 K243532 Contra Healthcare Solutions, LLC LumiRex Ureteroscope
2025-04-11 K243857 Shanghai AnQing Medical Instrument Co., Ltd. Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)
2025-03-27 K243708 Scivita Medical Technology Co., Ltd. Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)
2025-02-11 K243155 Dongguan Zsr Biomedical Technology Company Limited Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)
2025-01-29 K243117 Hunan Vathin Medical Instrument Co., Ltd. Digital Video Processor
2025-01-22 K241956 Hunan Endoso Life Technology Co., Ltd. Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)
2024-10-04 K241434 Hunan Vathin Medical Instrument Co., Ltd. Video Ureteroscope System
2024-10-04 K240074 Shenzhen Besdata Technology Co., Ltd. Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2)
2024-09-05 K240203 Dyne Medical Group, Inc. URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence