Cleared Traditional

K914212 - BARD SINGULAR BIOPSY FORCEPS

K914212 is the FDA 510(k) clearance for BARD SINGULAR BIOPSY FORCEPS by C.R. Bard, Inc.. It is a Class 1 Gastroenterology & Urology device (product code FCL) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K914212 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Nov 1991
Decision
69d
Days
Class 1
Risk

K914212 is an FDA 510(k) clearance for the BARD SINGULAR BIOPSY FORCEPS. Classified as Forceps, Biopsy, Non-electric (product code FCL), Class I - General Controls.

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on November 27, 1991 after a review of 69 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K914212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1991
Decision Date November 27, 1991
Days to Decision 69 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
61d faster than avg
Panel avg: 130d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 8
Devices cleared under the same product code (FCL) and FDA review panel - the closest regulatory comparables to K914212.
RITE-BITE BIOPSY FORCEPS
K951048 · Mill-Rose Laboratory · Mar 1995
DIENER RETRIEVAL DEVICES
K950559 · Mill-Rose Laboratory · Feb 1995
GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS
K935070 · KARL STORZ Endoscopy-America, Inc. · Jan 1994
BARD(R) DISPOSABLE BIOPSY FORCEPS
K912549 · C.R. Bard, Inc. · Sep 1991
BARD SINGULAR BIOPSY FORCEPS
K912214 · C.R. Bard, Inc. · May 1991
BIOPSY FORCEPS
K892252 · Zinnanti Surgical Instruments, Inc. · Oct 1989