Cleared Traditional

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)

K254294 is an FDA 510(k) clearance for Single-use Digital Hysteroscope (GYUT-A..., manufactured by Zhejiang Geyi Medical Instrument Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K254294 · Zhejiang Geyi Medical Instrument Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
251d
Days
Class 2
Risk

K254294 is an FDA 510(k) clearance for the Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6.... Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Zhejiang Geyi Medical Instrument Co., Ltd. (Jiande City, CN). The FDA issued a Cleared decision on September 8, 2026 after a review of 251 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1690 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Zhejiang Geyi Medical Instrument Co., Ltd. devices

FDA 510(k) Submission Details - K254294

510(k) Number K254294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2025
Decision Date September 08, 2026
Days to Decision 251 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 161d · This submission: 251d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIH Device Classification - Class 2, Special Controls

Product Code HIH Hysteroscope (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIH Hysteroscope (and Accessories)

All 158
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K254294.
UNIDRIVE SIII System
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K260984 · Axora Medical, Inc. · Aug 2026
Strauss Surgical Resection Instruments
K253020 · American Medical Endoscopy, Inc. · Jun 2026
Manual Tissue Removal Device
K254050 · Suzhou AcuVu Medical Technology Co., Ltd. · May 2026
InnovexView (GC146-17, GC150-20, GC155-23)
K254251 · Shanghai AnQing Medical Instrument Co., Ltd. · Feb 2026