Cleared Traditional

JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS

K134047 · Integra LifeSciences Corporation · Obstetrics & Gynecology
Apr 2014
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K134047 is an FDA 510(k) clearance for the JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS, a Forceps, Surgical, Gynecological (Class II — Special Controls, product code HCZ), submitted by Integra LifeSciences Corporation (York, US). The FDA issued a Cleared decision on April 11, 2014, 101 days after receiving the submission on December 31, 2013. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K134047 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 2013
Decision Date April 11, 2014
Days to Decision 101 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HCZ — Forceps, Surgical, Gynecological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530

Similar Devices — HCZ Forceps, Surgical, Gynecological

All 23
Fetzer Medical Gynecological Forceps
K172661 · Fetzer Medical GmbH & Co. KG · May 2018
INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL
K092840 · Instrumed International, Inc. · Dec 2009
FORCEPS, SURGICAL GYNECOLOGICAL
K944055 · Owens Precision Systems, Inc. · Sep 1994
PEARL PACKING FORCEPS
K941528 · Cook Urological, Inc. · May 1994
CORSON MYOMA GRASPING FORCEPS
K926484 · Thomasville Medical Assoc. · Feb 1994
HYSTERECTOMY FORCEPS
K926531 · Thomasville Medical Assoc. · Feb 1994