Home / 510(k) Clearances / K925501

510(k) K925501

NYLON COATED SPECULA by Zinnanti Surgical Instruments, Inc. — Product Code HIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1997
Date Received
October 30, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Speculum, Vaginal, Nonmetal
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Zinnanti Surgical Instruments, Inc.

  • 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)
  • K925960 — FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE (June 7, 1994)
  • K925957 — SCISSORS 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)
  • K925959 — FORCEPS FOR LAPAROSCOPIC SURGERY GU USE (November 12, 1993)

Other clearances for product code HIB

  • K252208 — JFord Speculum Sleeve™ (March 6, 2026)
  • K133857 — BRELLA-SPEC(TM) VAGINAL SPECULUM (April 28, 2014)
  • K132668 — IOB DISPOSABLE SPECULUM (January 17, 2014)
  • K130046 — CLEARSPEC SINGLE USE VAGINAL SPECULUM (August 6, 2013)
  • K120743 — SPECULUM, VAGINAL, NONMETAL (March 23, 2012)
  • K110766 — KOLPLUX SYSTEM (September 15, 2011)
  • K092870 — NON-STERILE DISPOSABLE VAGINAL SPECULUM (February 16, 2010)
  • K091937 — OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM (September 9, 2009)
  • K072942 — MEDLINE DISPOSABLE VAGINAL SPECULUM (February 8, 2008)
  • K072762 — DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM (January 22, 2008)