InnovexView (GC146-17, GC150-20, GC155-23)— 510(k) K254251

Clearance details

Applicant

Shanghai AnQing Medical Instrument Co., Ltd.

Product code

Code HIH

Device class

Class 2

Regulation

21 CFR 884.1690

Advisory panel

Obstetrics/Gynecology

Date received

2025-12-29

Decision date

2026-02-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shanghai, CN

• K254294 — 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)2026-09-08
• K260984 — HERizon RD5 Resecting Device (5FR1PK); HERizon RD5 Resecting Device - 5 pack (5FR5PK)2026-08-18
• K253020 — Strauss Surgical Resection Instruments2026-06-04
• K254050 — Manual Tissue Removal Device2026-05-15
• K252793 — ARMI® Endoscopic Video Image Processor (JY-MIP-3000) +1 more2025-12-18

• K252806 — Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)2025-10-03
• K252598 — Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)2025-09-15
• K251752 — Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)2025-08-27
• K243497 — Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US2025-05-29
• K243857 — Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)2025-04-11

Death

18

Injury

973

Malfunction

5,071

Other

1

Total

6,063

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →