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510(k) K891030

IUD HOOKS - SIMPLE, UNIVERSAL AND SKLAR by Zinnanti Surgical Instruments, Inc. — Product Code HHF

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
Remover, Intrauterine Device, Contraceptive, Hook-Type
Device Class
Class I
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Zinnanti Surgical Instruments, Inc.

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  • 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)
  • K926016 — NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE (November 12, 1993)

Other clearances for product code HHF

  • K926541 — IUD HOOKS (February 24, 1994)
  • K842295 — INTRAUTERINE DEVICE REMOVER (October 12, 1984)
  • K831568 — RELIANCE TEMPO OPHTH. INSTR STAND (June 30, 1983)
  • K820115 — EMMETT IUD THREAD RETREIVER (February 5, 1982)
  • K811761 — THE EMMETT IUD THREAD RETRIEVER (September 21, 1981)