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510(k) K891902

CHISELS- FREER, LUCAS, ALEXANDER, BISHOP by Zinnanti Surgical Instruments, Inc. — Product Code KGD

K891902 is an FDA 510(k) premarket notification submitted by Zinnanti Surgical Instruments, Inc. for the device "CHISELS- FREER, LUCAS, ALEXANDER, BISHOP". The FDA issued a decision of Substantially Equivalent on April 12, 1989. The device falls under product code KGD (Scissors For Cystoscope), a Class II device regulated under 21 CFR 876.1500. Zinnanti Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1989
Date Received
March 24, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scissors For Cystoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
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)
  • K926016 — NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE (November 12, 1993)

Other clearances for product code KGD

  • K944054 — POWDER FREE SURGEON'S GLOVE (November 17, 1994)

FDA data resources