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)— 510(k) K254294

Name: FDA 510(k) clearance K254294
Creator: U.S. Food and Drug Administration
Published: 2026-09-08

Substantially Equivalent

Zhejiang Geyi Medical Instrument Co., Ltd.

FDA 510(k) clearance K254294 for 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), Substantially Equivalent on 2026-09-08. Applicant: Zhejiang Geyi Medical Instrument Co., Ltd.. Device class: 2.

Summary

Zhejiang Geyi Medical Instrument's Single-use Digital Hysteroscope is cleared in 12 model configurations, all named GYUT-A or GYUT-B with numeric suffixes (for example GYUT-A 12.6- 0 and GYUT-B 15- 30). Product code HIH covers hysteroscopes and accessories. The record doesn't explain what the numbers in the model names mean.

Class II, 21 CFR 884.1690. Obstetrics/Gynecology is both the classification panel and the review panel. It was a Traditional 510(k), decided Substantially Equivalent.

The company filed from Jiande City, China. Review took 251 calendar days, from December 31, 2025 to September 8, 2026.

Clearance details

Applicant: Zhejiang Geyi Medical Instrument Co., Ltd.
Product code: Product code HIH
Device class: Class 2
Regulation: 21 CFR 884.1690
Advisory panel: Obstetrics/Gynecology
Date received: 2025-12-31
Decision date: 2026-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiande City, CN

Download summary PDF View on FDA.gov ↗

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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, 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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.