Cleared Traditional

K934598 - GRASPING FORCEPS OR RETRIEVAL FORCEPS

K934598 is an FDA 510(k) clearance for GRASPING FORCEPS OR RETRIEVAL FORCEPS, manufactured by Annex Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGO cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K934598 · Annex Medical, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jan 1994
Decision
105d
Days
Class 2
Risk

K934598 is an FDA 510(k) clearance for the GRASPING FORCEPS OR RETRIEVAL FORCEPS. Classified as Dislodger, Stone, Flexible (product code FGO), Class II - Special Controls.

Submitted by Annex Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on January 7, 1994 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4680 - 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 Annex Medical, Inc. devices

FDA 510(k) Submission Details - K934598

510(k) Number K934598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1993
Decision Date January 07, 1994
Days to Decision 105 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 130d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGO Device Classification - Class 2, Special Controls

Product Code FGO Dislodger, Stone, Flexible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FGO Dislodger, Stone, Flexible

All 9
Devices cleared under the same product code (FGO) and FDA review panel - the closest regulatory comparables to K934598.
DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE
K962676 · United States Endoscopy Group, Inc. · Oct 1996
STONE DISLODGER, BASKET
K951309 · Boston Scientific Corp · May 1995
GRASPING FORCEPS
K933261 · Surgitek · Jan 1994
INTRAVENOUS CATHETERS MODIFICATIONS
K921295 · Critikon Company, LLC · May 1993
GRASPING FORCEPS
K922542 · Surgitek · Aug 1992
RUBENSTEIN URETERAL STONE FRAGMENT BRUSH
K885168 · Boston Scientific Corp · Sep 1989