Cleared Traditional

K172661 - Fetzer Medical Gynecological Forceps

K172661 is the FDA 510(k) clearance for Fetzer Medical Gynecological Forceps by Fetzer Medical GmbH & Co. KG. It is a Class 2 Obstetrics & Gynecology device (product code HCZ) cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K172661 · Fetzer Medical GmbH & Co. KG · Obstetrics & Gynecology device
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May 2018
Decision
245d
Days
Class 2
Risk

K172661 is an FDA 510(k) clearance for the Fetzer Medical Gynecological Forceps. Classified as Forceps, Surgical, Gynecological (product code HCZ), Class II - Special Controls.

Submitted by Fetzer Medical GmbH & Co. KG (Tuttlingen, DE). The FDA issued a Cleared decision on May 8, 2018 after a review of 245 days - an extended review 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: 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 Fetzer Medical GmbH & Co. KG devices

Submission Details

510(k) Number K172661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2017
Decision Date May 08, 2018
Days to Decision 245 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
85d slower than avg
Panel avg: 160d · This submission: 245d
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 K172661.
JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS
K134047 · Integra LifeSciences Corporation · Apr 2014
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