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510(k) K891200

RIBBON TYPE SCISSORS: TENOTOMY,IRIS,EYE,STRABISMUS by Zinnanti Surgical Instruments, Inc. — Product Code LRW

K891200 is an FDA 510(k) premarket notification submitted by Zinnanti Surgical Instruments, Inc. for the device "RIBBON TYPE SCISSORS: TENOTOMY,IRIS,EYE,STRABISMUS". The FDA issued a decision of Substantially Equivalent on April 6, 1989. The device falls under product code LRW (Scissors, General, Surgical), a Class I device regulated under 21 CFR 878.4800. Zinnanti Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1989
Date Received
March 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scissors, General, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
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 LRW

  • K911158 — MICRO SCISSORS, 5MM CURVE MICRO SCISSORS, 5MM (March 29, 1991)
  • K902828 — SUTURE REMOVAL TRAY (August 8, 1990)
  • K900957 — GS-2100 HOOK SUTURE SCISSOR, 5MM (April 18, 1990)
  • K900950 — GS-2000 MICRO SCISSOR, CURVED LEFT, 5MM (April 18, 1990)
  • K892823 — PLASTER CUTTING SCISSORS (May 25, 1989)
  • K891889 — OLIVECORONA SCISSORS (April 12, 1989)
  • K891886 — SCISSORS, VARIOUS TYPES (April 12, 1989)
  • K891203 — SCISSORS: THOREK, JORGENSEN, FINOCHIETTO (April 6, 1989)
  • K890170 — SCISSORS (February 3, 1989)
  • K890235 — DRESSING SCISSORS (February 3, 1989)

FDA data resources