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510(k) K891043

ROTO FIT BIOPSY FORCEPS by Zinnanti Surgical Instruments, Inc. — Product Code HFB

K891043 is an FDA 510(k) premarket notification submitted by Zinnanti Surgical Instruments, Inc. for the device "ROTO FIT BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on March 22, 1989. The device falls under product code HFB (Forceps, Biopsy, Gynecological), a Class I device regulated under 21 CFR 884.4530. Zinnanti Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1989
Date Received
February 28, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Biopsy, Gynecological
Device Class
Class I
Regulation Number
884.4530
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)
  • 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 HFB

  • K011488 — SPIRABRUSH CX BIOPSY INSTRUMENT (February 22, 2002)
  • K944444 — CIT BIOPSY PUNCHES (September 29, 1995)
  • K930773 — SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS (July 28, 1994)
  • K933767 — FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY (May 26, 1994)
  • K926595 — OWENS BIOPSY FORCEPS (May 25, 1994)
  • K926527 — ROTO FIT BIOPSY FORCEPS (February 25, 1994)
  • K930036 — THOMAS MEDICAL BIOPSY FORCEPS (February 24, 1994)
  • K926538 — TISCHLER BIOPSY FORCEPS (February 24, 1994)
  • K924224 — OWENS BIOPSY FORCEPS (February 4, 1994)
  • K902049 — CROAK OVARIAN BIOPSY FORCEP (June 7, 1990)

FDA data resources