Cleared Traditional

K893636 - GUARDIAN FORCEP

K893636 is an FDA 510(k) clearance for GUARDIAN FORCEP, manufactured by Endo-Scientific, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code FCL cleared through the Traditional 510(k) pathway after a 332-day FDA review.

K893636 · Endo-Scientific, Inc. · Gastroenterology & Urology device
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Apr 1990
Decision
332d
Days
Class 1
Risk

K893636 is an FDA 510(k) clearance for the GUARDIAN FORCEP. Classified as Forceps, Biopsy, Non-electric (product code FCL), Class I - General Controls.

Submitted by Endo-Scientific, Inc. (Clearwater, US). The FDA issued a Cleared decision on April 9, 1990 after a review of 332 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.

FDA 510(k) Submission Details - K893636

510(k) Number K893636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1989
Decision Date April 09, 1990
Days to Decision 332 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
201d slower than avg
Panel avg: 131d · This submission: 332d
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 25
Devices cleared under the same product code (FCL) and FDA review panel - the closest regulatory comparables to K893636.
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
BIOPSY FORCEPS
K892252 · Zinnanti Surgical Instruments, Inc. · Oct 1989
BIOPSY FORCEPS
K840818 · American Endoscopy, Inc. · Apr 1984