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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 Jun 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 75 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 7, 1994
Date Received
Nov 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
510(k)

Other clearances by Zinnanti Surgical Instruments, Inc.

  • K925501 — NYLON COATED SPECULA (Jun 13, 1997)
  • K941458 — UTERINE MANIPULATOR/INJECTOR WITH SPRING (Jan 25, 1995)
  • K941457 — UTERINE INJECTOR WITH SPRING (Jan 24, 1995)
  • K925560 — ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES (Aug 30, 1994)
  • K925957 — SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE (Jun 7, 1994)
  • K926021 — NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE (Apr 7, 1994)
  • K925958 — SCISSOR FOR LAPAROSCOPIC SURGERY GU USE (Mar 24, 1994)
  • K926181 — ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY (Dec 17, 1993)
  • K925959 — FORCEPS FOR LAPAROSCOPIC SURGERY GU USE (Nov 12, 1993)
  • K926016 — NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE (Nov 12, 1993)

Other clearances for product code HFI

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

FDA data resources

Source: FDA 510(k) database entry for K925960. Report a data issue: hello@regdatalab.com.