Cleared Traditional

K911474 - LAPAROSCOPIC FORCEPS

K911474 is the FDA 510(k) clearance for LAPAROSCOPIC FORCEPS by United States Endoscopy Group, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HCZ) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K911474 · United States Endoscopy Group, Inc. · Obstetrics & Gynecology device
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Jul 1991
Decision
90d
Days
Class 2
Risk

K911474 is an FDA 510(k) clearance for the LAPAROSCOPIC FORCEPS. Classified as Forceps, Surgical, Gynecological (product code HCZ), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on July 3, 1991 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all United States Endoscopy Group, Inc. devices

Submission Details

510(k) Number K911474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1991
Decision Date July 03, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 160d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HCZ Forceps, Surgical, Gynecological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HCZ Forceps, Surgical, Gynecological

All 12
Devices cleared under the same product code (HCZ) and FDA review panel - the closest regulatory comparables to K911474.
Fetzer Medical Gynecological Forceps
K172661 · Fetzer Medical GmbH & Co. KG · May 2018
JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS
K134047 · Integra LifeSciences Corporation · Apr 2014
PEARL PACKING FORCEPS
K941528 · Cook Urological, Inc. · May 1994
DEFLECTING WIRE GRASPER
K903707 · Cook, Inc. · Sep 1990
HYSTERECTOMY FORCEPS - (SEVERAL MODELS)
K891036 · Zinnanti Surgical Instruments, Inc. · Mar 1989
ZEPPELIN FORCEPS
K891047 · Zinnanti Surgical Instruments, Inc. · Mar 1989