Cleared Traditional

K941816 - EMC FLEXIBLE BIOPSY FORCEPS

K941816 is an FDA 510(k) clearance for EMC FLEXIBLE BIOPSY FORCEPS, manufactured by Enterprise Medical Corp.. The device is a Class 1 Gastroenterology & Urology device with product code FCL cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K941816 · Enterprise Medical Corp. · Gastroenterology & Urology device
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Jul 1994
Decision
91d
Days
Class 1
Risk

K941816 is an FDA 510(k) clearance for the EMC FLEXIBLE BIOPSY FORCEPS. Classified as Forceps, Biopsy, Non-electric (product code FCL), Class I - General Controls.

Submitted by Enterprise Medical Corp. (Greensboro, US). The FDA issued a Cleared decision on July 13, 1994 after a review of 91 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 Enterprise Medical Corp. devices

FDA 510(k) Submission Details - K941816

510(k) Number K941816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1994
Decision Date July 13, 1994
Days to Decision 91 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
39d faster than avg
Panel avg: 130d · This submission: 91d
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 K941816.
RITE-BITE BIOPSY FORCEPS
K951048 · Mill-Rose Laboratory · Mar 1995
DIENER RETRIEVAL DEVICES
K950559 · Mill-Rose Laboratory · Feb 1995
SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS
K946238 · Symbiosis Corp. · Jan 1995
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