Cleared Traditional

BARD SINGULAR BIOPSY FORCEPS (K912214) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K912214 · C.R. Bard, Inc. · Gastroenterology & Urology device
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May 1991
Decision
10d
Days
Class 1
Risk

K912214 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. (Tewksbury, US). The FDA issued a Cleared decision on May 30, 1991 after a review of 10 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 K912214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1991
Decision Date May 30, 1991
Days to Decision 10 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
120d faster than avg
Panel avg: 130d · This submission: 10d
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.