LASER SPECULA— 510(k) K891044

Name: FDA 510(k) clearance K891044
Creator: U.S. Food and Drug Administration
Published: 1989-03-17

Substantially Equivalent

Zinnanti Surgical Instruments, Inc.

FDA 510(k) clearance K891044 for LASER SPECULA, Substantially Equivalent on 1989-03-17. Applicant: Zinnanti Surgical Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Zinnanti Surgical Instruments, Inc.
Product code: Code HDF
Device class: Class 1
Regulation: 21 CFR 884.4520
Advisory panel: Obstetrics/Gynecology
Date received: 1989-02-28
Decision date: 1989-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chatsworth, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HDF

view all

K926429 — VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT1994-02-28
K902019 — MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS1990-06-07
K891041 — MIYA SPECULUM1989-03-22
K890375 — VAGINAL SPECULUM1989-02-13
K862478 — HAYES VAGINAL SHIELD1986-11-24

More clearances from Zinnanti Surgical Instruments, Inc.

view all

K925501 — NYLON COATED SPECULA1997-06-13
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

Adverse events under product code HDF

product code HDF

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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