Cleared Traditional

K912549 - BARD(R) DISPOSABLE BIOPSY FORCEPS

K912549 is an FDA 510(k) clearance for BARD DISPOSABLE BIOPSY FORCEPS, manufactured by C.R. Bard, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code FCL cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K912549 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Sep 1991
Decision
92d
Days
Class 1
Risk

K912549 is an FDA 510(k) clearance for the BARD(R) DISPOSABLE BIOPSY FORCEPS. Classified as Forceps, Biopsy, Non-electric (product code FCL), Class I - General Controls.

Submitted by C.R. Bard, Inc. (Tewksbury, US). The FDA issued a Cleared decision on September 10, 1991 after a review of 92 days - within the typical 510(k) review window.

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.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K912549

510(k) Number K912549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1991
Decision Date September 10, 1991
Days to Decision 92 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 131d · This submission: 92d
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 19
Devices cleared under the same product code (FCL) and FDA review panel - the closest regulatory comparables to K912549.
SYMBIOSIS DISPOS PULMON BIOPSY FORCEPS W/REUS HAND
K932265 · Symbiosis Corp. · Aug 1993
FUJINON FORCEPS -- MODIFICATION
K922396 · Hobbs Medical, Inc. · Dec 1992
BARD SINGULAR BIOPSY FORCEPS
K914212 · C.R. Bard, Inc. · Nov 1991
BARD SINGULAR BIOPSY FORCEPS
K912214 · C.R. Bard, Inc. · May 1991
BIOPSY FORCEPS
K892252 · Zinnanti Surgical Instruments, Inc. · Oct 1989
BIOPSY FORCEPS
K840818 · American Endoscopy, Inc. · Apr 1984