Cleared Traditional

K911474 - LAPAROSCOPIC FORCEPS

K911474 is an FDA 510(k) clearance for LAPAROSCOPIC FORCEPS, manufactured by United States Endoscopy Group, Inc.. The device is a Class 2 Obstetrics & Gynecology device with 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

FDA 510(k) Submission Details - K911474

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.

HCZ Device Classification - Class 2, Special Controls

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 20
Devices cleared under the same product code (HCZ) and FDA review panel - the closest regulatory comparables to K911474.
OVUM FORCEPS
K926528 · Thomasville Medical Assoc. · Feb 1994
FORCEPS: MCGRAVEY, MCINDOE, GILLIS
K930039 · Thomasville Medical Assoc. · Feb 1994
VARIOUS FORCEPS
K930799 · Thomasville Medical Assoc. · Feb 1994
DEFLECTING WIRE GRASPER
K903707 · Cook, Inc. · Sep 1990
ZEPPELIN FORCEPS
K901897 · Kirwan Surgical Products, Inc. · Jun 1990
HYSTERECTOMY FORCEPS - (SEVERAL MODELS)
K891036 · Zinnanti Surgical Instruments, Inc. · Mar 1989