Cleared Traditional

K160625 - Disposable Hot Biopsy Forceps

K160625 is an FDA 510(k) clearance for Disposable Hot Biopsy Forceps, manufactured by Micro-Tech (Nanjing) Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KGE cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K160625 · Micro-Tech (Nanjing) Co., Ltd. · Gastroenterology & Urology device
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Jun 2016
Decision
102d
Days
Class 2
Risk

K160625 is an FDA 510(k) clearance for the Disposable Hot Biopsy Forceps. Classified as Forceps, Biopsy, Electric (product code KGE), Class II - Special Controls.

Submitted by Micro-Tech (Nanjing) Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on June 14, 2016 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Micro-Tech (Nanjing) Co., Ltd. devices

FDA 510(k) Submission Details - K160625

510(k) Number K160625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2016
Decision Date June 14, 2016
Days to Decision 102 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 131d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KGE Device Classification - Class 2, Special Controls

Product Code KGE Forceps, Biopsy, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KGE Forceps, Biopsy, Electric

All 37
Devices cleared under the same product code (KGE) and FDA review panel - the closest regulatory comparables to K160625.
Single Use Hot Biopsy Forceps FD-231
K171916 · Olympus Medical Systems Corp. · Oct 2017
Fujifilm Diathermic Slitter (FlushKnife)
K171096 · Fujifilm Medical Systems U.S.A, Inc. · May 2017
Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)
K161186 · Fujifilm Medical Systems U.S.A, Inc. · Jun 2016
Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)
K151474 · Fujifilm Medical System U.S.A., Inc. · Feb 2016
ENDO-MARYLAND DISSECTOR
K141794 · Ovesco Endoscopy AG · Nov 2014
ENDOCHOICE HOT BIOPSY FORCEPS
K131991 · Endochoice, Inc. · Oct 2013