MICRO CLIP STERILIZING CASE #65199— 510(k) K801470

Name: FDA 510(k) clearance K801470
Creator: U.S. Food and Drug Administration
Published: 1980-07-14

Substantially Equivalent

Edward Weck, Inc.

FDA 510(k) clearance K801470 for MICRO CLIP STERILIZING CASE #65199, Substantially Equivalent on 1980-07-14. Applicant: Edward Weck, Inc.. Device class: 1.

Clearance details

Applicant: Edward Weck, Inc.
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1980-06-24
Decision date: 1980-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FSM

view all

K971217 — INSTRUMENT TRAY LINER1997-05-06
K962328 — SINGLE USE INSTRUMENT TRAY1996-08-09
K944025 — SURGICAL INSTRUMENT TRAY1994-11-22
K912106 — ARTHROSCOPY TRAY1991-08-29
K912053 — OPEN HEART TRAY1991-08-26

More clearances from Edward Weck, Inc.

view all

K915378 — WECK TROCAR1992-06-29
K914690 — LM15(TM), CATALOG NUMBER - 5238211992-03-23
K911915 — HEMOCLIP II1992-01-09
K914470 — PNEUMO-SEAL(TM)1991-11-29
K911272 — ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 1147051991-07-02

Adverse events under product code FSM

product code FSM

Malfunction: 1,289
Total: 1,289

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.