Cleared Traditional

K254050 - Manual Tissue Removal Device

K254050 is an FDA 510(k) clearance for Manual Tissue Removal Device, manufactured by Suzhou AcuVu Medical Technology Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K254050 · Suzhou AcuVu Medical Technology Co., Ltd. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
May 2026
Decision
149d
Days
Class 2
Risk

K254050 is an FDA 510(k) clearance for the Manual Tissue Removal Device. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Suzhou AcuVu Medical Technology Co., Ltd. (Suzhou, Jiangsu, CN). The FDA issued a Cleared decision on May 15, 2026 after a review of 149 days - within the typical 510(k) review window.

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 Suzhou AcuVu Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K254050

510(k) Number K254050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2025
Decision Date May 15, 2026
Days to Decision 149 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
11d faster than avg
Panel avg: 160d · This submission: 149d
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 143
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K254050.
HERizon RD5 Resecting Device (5FR1PK)
K260984 · Axora Medical, Inc. · Aug 2026
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K254251 · Shanghai AnQing Medical Instrument Co., Ltd. · Feb 2026
ARMI® Endoscopic Video Image Processor (JY-MIP-3000)
K252793 · Jiangsu Jiyuan Medical Technology Co., Ltd. · Dec 2025
SPY Cystoscope/Hysteroscope
K252012 · Stryker Endoscopy · Jul 2025
RZ Resectoscope System
K243382 · Rz Medizintechnik GmbH · Jun 2025