Cleared Traditional

K941528 - PEARL PACKING FORCEPS

K941528 is the FDA 510(k) clearance for PEARL PACKING FORCEPS by Cook Urological, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HCZ) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K941528 · Cook Urological, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
43d
Days
Class 2
Risk

K941528 is an FDA 510(k) clearance for the PEARL PACKING FORCEPS. Classified as Forceps, Surgical, Gynecological (product code HCZ), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on May 12, 1994 after a review of 43 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cook Urological, Inc. devices

Submission Details

510(k) Number K941528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1994
Decision Date May 12, 1994
Days to Decision 43 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 160d · This submission: 43d
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 K941528.
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
LAPAROSCOPIC FORCEPS
K911474 · United States Endoscopy Group, Inc. · Jul 1991
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