Cleared Traditional

K914497 - BIOPSY FORCEPS

K914497 is an FDA 510(k) clearance for BIOPSY FORCEPS, manufactured by Surgitek Medical Engineering Corp.. The device is a Class 1 Gastroenterology & Urology device with product code FCL cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K914497 · Surgitek Medical Engineering Corp. · Gastroenterology & Urology device
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Jan 1992
Decision
87d
Days
Class 1
Risk

K914497 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 Surgitek Medical Engineering Corp. (Racine, US). The FDA issued a Cleared decision on January 3, 1992 after a review of 87 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 Surgitek Medical Engineering Corp. devices

FDA 510(k) Submission Details - K914497

510(k) Number K914497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1991
Decision Date January 03, 1992
Days to Decision 87 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 130d · This submission: 87d
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 12
Devices cleared under the same product code (FCL) and FDA review panel - the closest regulatory comparables to K914497.
SYMBIOSIS DISPOSABLE UROLOGICAL BIOPSY FORCEPS
K931957 · Symbiosis Corp. · Feb 1994
GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS
K935070 · KARL STORZ Endoscopy-America, Inc. · Jan 1994
SYMBIOSIS DISPOS PULMON BIOPSY FORCEPS W/REUS HAND
K932265 · Symbiosis Corp. · Aug 1993
BARD SINGULAR BIOPSY FORCEPS
K914212 · C.R. Bard, Inc. · Nov 1991
BARD(R) DISPOSABLE BIOPSY FORCEPS
K912549 · C.R. Bard, Inc. · Sep 1991
BARD SINGULAR BIOPSY FORCEPS
K912214 · C.R. Bard, Inc. · May 1991