HIH · Hysteroscope (And Accessories) · Chrysalis Intelligence

Device class

Class II

Regulation 884.1690

Total clearances

2020-01-16 → 2026-09-25

Last 12 months

Unique sponsors

Classification details

Medical specialty

Obstetrics/Gynecology

Review panel

Regulation number

884.1690

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
Caldera Medical, Inc.	3	0	2023-11-30
Jiangsu Jiyuan Medical Technology Co., Ltd.	2	1	2025-12-18
Suzhou AcuVu Medical Technology Co., Ltd.	2	1	2026-05-15
Stryker Endoscopy	2	0	2025-07-18
Meditrina, Inc.	2	0	2023-08-21
Karl Storz SE & CO. KG	2	2	2026-09-25
Guangzhou Red Pine Medical Instrument Co., Ltd.	2	0	2024-08-02
Zhejiang Geyi Medical Instrument Co., Ltd.	1	1	2026-09-08
Rz Medizintechnik GmbH	1	0	2025-06-03
Lina Medical Aps	1	0	2020-01-17
Boston Scientific Corporation	1	0	2020-01-16
CooperSurgical, Inc.	1	0	2020-02-05
Schoelly Fiberoptic GmbH	1	0	2020-10-08
Stryker Sustainability Solutions	1	0	2020-09-25
Hysterovue, Inc.	1	0	2021-11-23
Karl Storz Endoscopy America, Inc.	1	0	2023-09-14
Olympus Winter & Ibe GmbH	1	0	2021-12-22
Olympus Medical Systems Corporation	1	0	2022-09-02
Axora Medical, Inc.	1	1	2026-08-18
American Medical Endoscopy, Inc.	1	1	2026-06-04
MacroLux Medical Technology Co., Ltd.	1	0	2024-08-16
Karl Storz-Endoscopy-America, Inc.	1	0	2023-04-27
Acuvu, Inc.	1	0	2021-09-15
Origyn Medical Technology (Hangzhou) Co., Ltd.	1	0	2024-07-26
Shanghai AnQing Medical Instrument Co., Ltd.	1	1	2026-02-26

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.

Code	Type	Description	Confidence	Rationale
58555	CPT	—	High	Standard CPT for hysteroscopy, diagnostic, with or without biopsy
58560	CPT	—	Medium	Hysteroscopy with division/resection of septum or adhesions

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-25	K254252	Karl Storz SE & CO. KG	UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)
2026-09-18	K261102	Karl Storz SE & CO. KG	UNIDRIVE Select System
2026-09-08	K254294	Zhejiang Geyi Medical Instrument Co., Ltd.	Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)
2026-08-18	K260984	Axora Medical, Inc.	HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)
2026-06-04	K253020	American Medical Endoscopy, Inc.	Strauss Surgical Resection Instruments
2026-05-15	K254050	Suzhou AcuVu Medical Technology Co., Ltd.	Manual Tissue Removal Device
2026-02-26	K254251	Shanghai AnQing Medical Instrument Co., Ltd.	InnovexView (GC146-17, GC150-20, GC155-23)
2025-12-18	K252793	Jiangsu Jiyuan Medical Technology Co., Ltd.	ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)
2025-07-18	K252012	Stryker Endoscopy	SPY Cystoscope/Hysteroscope
2025-06-03	K243382	Rz Medizintechnik GmbH	RZ Resectoscope System
2024-08-16	K240978	MacroLux Medical Technology Co., Ltd.	SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)
2024-08-02	K241987	Guangzhou Red Pine Medical Instrument Co., Ltd.	Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
2024-07-26	K240401	Origyn Medical Technology (Hangzhou) Co., Ltd.	ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)
2024-03-05	K231260	Suzhou AcuVu Medical Technology Co., Ltd.	HTx Disposable Hysteroscope System
2024-02-12	K233635	Stryker Endoscopy	SPY Cystoscope/Hysteroscope
2024-02-12	K232003	Guangzhou Red Pine Medical Instrument Co., Ltd.	Endoscopic Video Image Processor, Single-Use Video Hysteroscope
2023-11-30	K233500	Caldera Medical, Inc.	Benesta Tissue Removal Device
2023-09-14	K223885	Karl Storz Endoscopy America, Inc.	HOPKINS Telescopes
2023-08-21	K223813	Meditrina, Inc.	Aveta System 2.0
2023-04-27	K223520	Karl Storz-Endoscopy-America, Inc.	UNIDRIVE SIII System
2022-09-02	K221557	Olympus Medical Systems Corporation	Visera Hysterovideoscope Olympus HYF Type V
2022-05-26	K213171	Meditrina, Inc.	Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)
2021-12-22	K213207	Olympus Winter & Ibe GmbH	Sheath, Stopcock Accessory
2021-11-23	K202445	Hysterovue, Inc.	Hystero-V Hysteroscope
2021-10-01	K210270	Jiangsu Jiyuan Medical Technology Co., Ltd.	Medical Endoscope Image Processing System