Chrysalis Intelligence · Product Codes · KNS

KNS · Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Gastroenterology, Urology · 36 clearances · 17 unique sponsors

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Device class
Class II
Regulation 876.4300
Total clearances
36
2020-01-30 → 2026-09-03
Last 12 months
6
Unique sponsors
17
Classification details
Medical specialty
Gastroenterology, Urology
Review panel
GU
Regulation number
876.4300
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Boston Scientific Corporation 7 1 2026-09-03
Creo Medical, Ltd. 4 0 2025-06-06
Aqua Medical, Inc. 4 0 2025-08-08
Hangzhou AGS MedTech Co., Ltd. 3 0 2023-05-03
Wilson-Cook Medical, Inc. 3 0 2025-09-29
Olympus Medical Systems Corporation 3 3 2025-11-25
Taewoong Medical Co., Ltd. 2 1 2026-05-21
Sb-Kawasumi Laboratories, Inc. 1 0 2025-03-26
Starmed Co., Ltd. 1 0 2023-10-25
Jiangsu Vedkang Medical Science and Technology Co., Ltd. 1 0 2024-03-29
Anrei Medical (Hangzhou) Co., Ltd. 1 0 2022-03-21
G-Flex Europe Sprl 1 0 2022-06-09
Zhejiang Soudon Medical Technology Co., Ltd. 1 0 2023-11-07
Francis Medical, Inc. 1 1 2025-11-26
Micro-Tech (Nanjing) Co., Ltd. 1 0 2021-12-01
Lamidey Noury Medical 1 0 2022-09-21
Beijing Zksk Technology Co., Ltd. 1 0 2025-02-06
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
43452 CPT — High Standard CPT for endoscopic hemostasis with electrosurgical coagulation
45382 CPT — High Standard CPT for colonoscopy with electrosurgical procedures
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-09-03 K262460 Boston Scientific Rezum System
2026-05-21 K260962 Taewoong Medical Co., Ltd. Sphincterotome
2025-11-26 K252388 Francis Medical, Inc. Vanquish Water Vapor Ablation Device
2025-11-25 K252889 Olympus Medical Systems Corporation Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
2025-10-17 K250945 Olympus Medical Systems Corp. Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)
2025-10-10 K250351 Olympus Medical Systems Corporation Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)
2025-09-29 K251104 Wilson-Cook Medical SureTome™ SW Sphincterotome with DomeTip
2025-08-08 K251226 Aqua Medical, Inc. Aqua Medical RF Vapor Ablation System
2025-06-11 K250584 Boston Scientific Corporation Rezum System
2025-06-06 K242774 Creo Medical, Ltd. SpydrBlade Flex Instrument (PRD-RG1-001)
2025-03-26 K241855 Sb-Kawasumi Laboratories, Inc. SB Knife Jr2 (MD-47702 and MD-47702L)
2025-02-06 K242192 Beijing Zksk Technology Co., Ltd. Disposable Sphincterotome
2025-01-17 K243568 Wilson-Cook Medical, Inc. Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord
2024-12-12 K241271 Aqua Medical, Inc. Aqua Medical RF Vapor Ablation System
2024-08-15 K242061 Creo Medical, Ltd. Reusable Interface Cable 1.5 m (PRD-IFC-002)
2024-03-29 K232825 Jiangsu Vedkang Medical Science and Technology Co., Ltd. Disposable Sphincterotome
2023-11-28 K232633 Boston Scientific Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter
2023-11-07 K232476 Zhejiang Soudon Medical Technology Co., Ltd. Disposable Sphincterotome
2023-10-31 K230328 Creo Medical, Ltd. Speedboat Flush SB1 Instrument
2023-10-27 K233318 Boston Scientific Corporation AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm)
2023-10-25 K233113 Starmed Co., Ltd. ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)
2023-08-14 K232162 Boston Scientific Corporation Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome
2023-06-21 K231533 Boston Scientific Corporation Habib EndoHPB
2023-05-03 K222421 Hangzhou AGS MedTech Co., Ltd. Sphincterotome
2023-04-05 K223256 Taewoong Medical Co., Ltd. Optimos™ Cystotome
Data source: openFDA · Generated 2026-10-08 10:51 · Last ingest 2026-10-08T14:51:39.242493 · Pipeline: Chrysalis Intelligence