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510(k) K172661

Fetzer Medical Gynecological Forceps by Fetzer Medical GmbH & Co. KG — Product Code HCZ

K172661 is an FDA 510(k) premarket notification submitted by Fetzer Medical GmbH & Co. KG for the device "Fetzer Medical Gynecological Forceps". The FDA issued a decision of Substantially Equivalent on May 8, 2018. The device falls under product code HCZ (Forceps, Surgical, Gynecological), a Class II device regulated under 21 CFR 884.4530. Fetzer Medical GmbH & Co. KG has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2018
Date Received
September 5, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Surgical, Gynecological
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Fetzer Medical GmbH & Co. KG

  • K163524 — Vessel Dilator (June 29, 2017)
  • K161004 — Self-retaining Retractor (September 9, 2016)

Other clearances for product code HCZ

  • K134047 — JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOI (April 11, 2014)
  • K092840 — INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL (December 3, 2009)
  • K944055 — FORCEPS, SURGICAL GYNECOLOGICAL (September 20, 1994)
  • K941528 — PEARL PACKING FORCEPS (May 12, 1994)
  • K926533 — Z-CLAMP FORCEPS (February 25, 1994)
  • K926531 — HYSTERECTOMY FORCEPS (February 25, 1994)
  • K926484 — CORSON MYOMA GRASPING FORCEPS (February 25, 1994)
  • K926528 — OVUM FORCEPS (February 24, 1994)
  • K930799 — VARIOUS FORCEPS (February 24, 1994)
  • K930039 — FORCEPS: MCGRAVEY, MCINDOE, GILLIS (February 24, 1994)

FDA data resources