Cleared Traditional

K901897 - ZEPPELIN FORCEPS

K901897 is the FDA 510(k) clearance for ZEPPELIN FORCEPS by Kirwan Surgical Products, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HCZ) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K901897 · Kirwan Surgical Products, Inc. · Obstetrics & Gynecology device
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Jun 1990
Decision
65d
Days
Class 2
Risk

K901897 is an FDA 510(k) clearance for the ZEPPELIN FORCEPS. Classified as Forceps, Surgical, Gynecological (product code HCZ), Class II - Special Controls.

Submitted by Kirwan Surgical Products, Inc. (Rockland, US). The FDA issued a Cleared decision on June 29, 1990 after a review of 65 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 Kirwan Surgical Products, Inc. devices

Submission Details

510(k) Number K901897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1990
Decision Date June 29, 1990
Days to Decision 65 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 160d · This submission: 65d
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 13
Devices cleared under the same product code (HCZ) and FDA review panel - the closest regulatory comparables to K901897.
PEARL PACKING FORCEPS
K941528 · Cook Urological, Inc. · May 1994
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
HYSTERECTOMY FORCEPS
K890383 · Kinetic Medical Products · Feb 1989