Cleared Traditional

EMC FLEXIBLE BIOPSY FORCEPS (K941816) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

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

Submission Details

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.

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.