Fetzer Medical Gynecological Forceps— 510(k) K172661

Clearance details

Applicant

Fetzer Medical GmbH & Co. KG

Product code

Code HCZ

Device class

Class 2

Regulation

21 CFR 884.4530

Advisory panel

Obstetrics/Gynecology

Date received

2017-09-05

Decision date

2018-05-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Tuttlingen, DE

• K134047 — JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS2014-04-11
• K092840 — INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL2009-12-03
• K944055 — FORCEPS, SURGICAL GYNECOLOGICAL1994-09-20
• K941528 — PEARL PACKING FORCEPS1994-05-12
• K926484 — CORSON MYOMA GRASPING FORCEPS1994-02-25

• K163524 — Vessel Dilator2017-06-29
• K161004 — Self-retaining Retractor2016-09-09

• Z-0755-2019 — 16600 / Fetzer Surgical Luikart Simpson OB Forceps14" (35.5cm), Item No./Product Code 46-5050 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other.Class II·Terminated·Fetzer Medical GmbH & Co. KG·20181228
• Z-0756-2019 — 12002 / Boss Instruments Ltd. Wrigley Obstetric Forceps, 11" (28cm), Item No./Product Code 46-5004 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other.Class II·Terminated·Fetzer Medical GmbH & Co. KG·20181228
• Z-0757-2019 — 16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Product Code 46-5034 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other.Class II·Terminated·Fetzer Medical GmbH & Co. KG·20181228
• Z-0758-2019 — 12002 / Boss Instruments Simpson OB Forceps, short model, 13" (33cm), Item No./Product Code 46-5040 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other.Class II·Terminated·Fetzer Medical GmbH & Co. KG·20181228

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172661.