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510(k) K891898

SKIN HOOKS, VARIOUS TYPES by Zinnanti Surgical Instruments, Inc. — Product Code GDG

K891898 is an FDA 510(k) premarket notification submitted by Zinnanti Surgical Instruments, Inc. for the device "SKIN HOOKS, VARIOUS TYPES". The FDA issued a decision of Substantially Equivalent on April 12, 1989. The device falls under product code GDG (Hook, Surgical, General & Plastic Surgery), 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 12, 1989
Date Received
March 24, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hook, Surgical, General & Plastic Surgery
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 GDG

  • K900069 — MODIFIED PGL ABSORBABLE STAPLE* (April 16, 1990)
  • K864425 — RAYLOR(TM) DISSECTING HOOK (December 12, 1986)
  • K843136 — BRIMFIELD CANNULATED GRASPING HOOKS (September 25, 1984)
  • K841010 — SURGICAL HOOKS, VARIOUS (May 1, 1984)
  • K812562 — SURGICAL RETRACTOR & ELASTIC STAYS, DISP (October 2, 1981)
  • K791120 — MIDDLE EAR PICKS, HOOKS CURETTES, (July 10, 1979)
  • K780289 — NERVE APPROXIMATER (June 14, 1978)
  • K771187 — DERMAHOOK #382-805 (July 11, 1977)
  • K771190 — ABRAMSON TRACHEA HOOK & RETRACTOR (July 11, 1977)

FDA data resources