InnovexView (GC146-17, GC150-20, GC155-23)— 510(k) K254251
Substantially EquivalentShanghai AnQing Medical Instrument Co., Ltd.
FDA 510(k) clearance K254251 for InnovexView (GC146-17, GC150-20, GC155-23), Substantially Equivalent on 2026-02-26. Applicant: Shanghai AnQing Medical Instrument Co., Ltd.. Device class: 2.
Summary
Shanghai AnQing Medical Instrument's InnovexView lists three designations in its name: GC146-17, GC150-20, and GC155-23. It's filed under product code HIH, hysteroscope (and accessories), and the record doesn't say how the three differ.
Class II, 21 CFR 884.1690. Obstetrics/Gynecology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Shanghai AnQing Medical Instrument filed from Shanghai, China. The decision came 59 calendar days after FDA received it (December 29, 2025 to February 26, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Shanghai AnQing Medical Instrument Co., Ltd.
- Product code
- Product code HIH
- Device class
- Class 2
- Regulation
- 21 CFR 884.1690
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
Recent devices under product code HIH
view all- K254252 — UNIDRIVE SIII System +1 more
- K261102 — UNIDRIVE Select System
- 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)
- K260984 — HERizon RD5 Resecting Device (5FR1PK); HERizon RD5 Resecting Device - 5 pack (5FR5PK)
- K253020 — Strauss Surgical Resection Instruments
More clearances from Shanghai AnQing Medical Instrument Co., Ltd.
view all- K252806 — Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)
- K252598 — Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
- K251752 — Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)
- 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-28US
- K243857 — Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)
Adverse events under product code HIH
product code HIH- Death
- 18
- Injury
- 973
- Malfunction
- 5,071
- Other
- 1
- Total
- 6,063
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.