HIH · Hysteroscope (And Accessories) · Chrysalis Intelligence

Device class

Class II

Regulation 884.1690

Total clearances

2020-01-16 → 2026-06-04

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

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
2026-06-04	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
2021-09-15	K211227	Acuvu, Inc.	HTx Disposable Hysteroscope System
2020-10-23	K192811	Caldera Medical, Inc.	BenestaTM Tissue Removal Device
2020-10-08	K201970	Schoelly Fiberoptic GmbH	Schoelly Cystoscopes/Hysteroscopes and Accessories
2020-09-25	K201756	Stryker Sustainability Solutions	Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent