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510(k) K925960

FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE by Zinnanti Surgical Instruments, Inc. — Product Code HFI

K925960 is an FDA 510(k) premarket notification submitted by Zinnanti Surgical Instruments, Inc. for the device "FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE". The FDA issued a decision of Substantially Equivalent on June 7, 1994. The device falls under product code HFI (Coagulator, Culdoscopic (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Zinnanti Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1994
Date Received
November 24, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator, Culdoscopic (And Accessories)
Device Class
Class II
Regulation Number
884.4160
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)
  • 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)
  • K926016 — NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE (November 12, 1993)

Other clearances for product code HFI

  • K151567 — ENDOPLUS hand-held laparoscopic instruments (December 23, 2015)
  • K925957 — SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE (June 7, 1994)
  • K936026 — COOK LAPAROSCOPIC MINI RETRACTOR SET (March 11, 1994)
  • K924148 — DIAMOND-SHARP(R) TROCARS (February 28, 1994)
  • K925114 — LAPAROSCOPIC INSTRUMENTS (February 28, 1994)
  • K930571 — REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING (February 1, 1994)
  • K844053 — CANON 60 DEGREE FUNDUS CAMERA CF-60S (December 19, 1984)

FDA data resources