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510(k) K891036

HYSTERECTOMY FORCEPS - (SEVERAL MODELS) by Zinnanti Surgical Instruments, Inc. — Product Code HCZ

K891036 is an FDA 510(k) premarket notification submitted by Zinnanti Surgical Instruments, Inc. for the device "HYSTERECTOMY FORCEPS - (SEVERAL MODELS)". The FDA issued a decision of Substantially Equivalent on March 17, 1989. The device falls under product code HCZ (Forceps, Surgical, Gynecological), a Class II device regulated under 21 CFR 884.4530. Zinnanti Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1989
Date Received
February 28, 1989
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 Zinnanti Surgical Instruments, Inc.

  • K925501 — NYLON COATED SPECULA (June 13, 1997)
  • K941458 — UTERINE MANIPULATOR/INJECTOR WITH SPRING (January 25, 1995)
  • K941457 — UTERINE INJECTOR WITH SPRING (January 24, 1995)
  • K925560 — ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES (August 30, 1994)
  • K925957 — SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE (June 7, 1994)
  • K925960 — FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE (June 7, 1994)
  • K926021 — NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE (April 7, 1994)
  • K925958 — SCISSOR FOR LAPAROSCOPIC SURGERY GU USE (March 24, 1994)
  • K926181 — ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY (December 17, 1993)
  • K925959 — FORCEPS FOR LAPAROSCOPIC SURGERY GU USE (November 12, 1993)

Other clearances for product code HCZ

  • K172661 — Fetzer Medical Gynecological Forceps (May 8, 2018)
  • 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)

FDA data resources