Cleared Traditional

K931957 - SYMBIOSIS DISPOSABLE UROLOGICAL BIOPSY FORCEPS (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K931957 · Symbiosis Corp. · Gastroenterology & Urology device
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Feb 1994
Decision
314d
Days
Class 1
Risk

K931957 is an FDA 510(k) clearance for the SYMBIOSIS DISPOSABLE UROLOGICAL BIOPSY FORCEPS. Classified as Forceps, Biopsy, Non-electric (product code FCL), Class I - General Controls.

Submitted by Symbiosis Corp. (Miami, US). The FDA issued a Cleared decision on February 28, 1994 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

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Submission Details

510(k) Number K931957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1993
Decision Date February 28, 1994
Days to Decision 314 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
184d slower than avg
Panel avg: 130d · This submission: 314d
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.