Cleared Traditional

K892252 - BIOPSY FORCEPS

K892252 is an FDA 510(k) clearance for BIOPSY FORCEPS, manufactured by Zinnanti Surgical Instruments, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code FCL cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K892252 · Zinnanti Surgical Instruments, Inc. · Gastroenterology & Urology device
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Oct 1989
Decision
182d
Days
Class 1
Risk

K892252 is an FDA 510(k) clearance for the BIOPSY FORCEPS. Classified as Forceps, Biopsy, Non-electric (product code FCL), Class I - General Controls.

Submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on October 3, 1989 after a review of 182 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - 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.

FDA 510(k) Submission Details - K892252

510(k) Number K892252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1989
Decision Date October 03, 1989
Days to Decision 182 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 131d · This submission: 182d
Pathway characteristics
Predicate-based equivalence.

FCL Device Classification - Class 1, General Controls

Product Code FCL Forceps, Biopsy, Non-electric
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1075
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FCL Forceps, Biopsy, Non-electric

All 38
Devices cleared under the same product code (FCL) and FDA review panel - the closest regulatory comparables to K892252.
GUARDIAN FORCEP
K893636 · Endo-Scientific, Inc. · Apr 1990
NON-ELECTRIC BIOPSY FORCEPS
K900015 · Esco Precision, Inc. · Mar 1990
NON-ELECTRIC BIOPSY FORCEPS
K900065 · Esco Precision, Inc. · Mar 1990
HUFFMAN BIOPSY UNIT
K873176 · Penn Medical Devices, Inc. · Oct 1987
BIOPSY FORCEPS
K871710 · Frantz Medical Development, Ltd. · Aug 1987
HOBBS MEDICAL /JAYCO MULTIPLE BIOPSY INSTRUMENT
K844551 · Gobbs Medical, Inc. · Jan 1985
K892252 · BIOPSY FORCEPS
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