NYLON COATED SPECULA— 510(k) K925501

Name: FDA 510(k) clearance K925501
Creator: U.S. Food and Drug Administration
Published: 1997-06-13

Substantially Equivalent

Zinnanti Surgical Instruments, Inc.

FDA 510(k) clearance K925501 for NYLON COATED SPECULA, Substantially Equivalent on 1997-06-13. Applicant: Zinnanti Surgical Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Zinnanti Surgical Instruments, Inc.
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1992-10-30
Decision date: 1997-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chatsworth, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HIB

view all

K252208 — JFord Speculum Sleeve2026-03-06
K133857 — BRELLA-SPEC(TM) VAGINAL SPECULUM2014-04-28
K132668 — IOB DISPOSABLE SPECULUM2014-01-17
K130046 — CLEARSPEC SINGLE USE VAGINAL SPECULUM2013-08-06
K120743 — SPECULUM, VAGINAL, NONMETAL2012-03-23

More clearances from Zinnanti Surgical Instruments, Inc.

view all

K941458 — UTERINE MANIPULATOR/INJECTOR WITH SPRING1995-01-25
K941457 — UTERINE INJECTOR WITH SPRING1995-01-24
K925560 — ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES1994-08-30
K925957 — SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE1994-06-07
K925960 — FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE1994-06-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.