OPERATING ROOM KIT— 510(k) K811916

Name: FDA 510(k) clearance K811916
Creator: U.S. Food and Drug Administration
Published: 1981-10-14

Substantially Equivalent

American Hospital Supply Corp.

FDA 510(k) clearance K811916 for OPERATING ROOM KIT, Substantially Equivalent on 1981-10-14. Applicant: American Hospital Supply Corp.. Device class: 1.

Clearance details

Applicant: American Hospital Supply Corp.
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1981-07-01
Decision date: 1981-10-14
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 American Hospital Supply Corp.

view all

K854739 — AMERICAN STERILE SURGICAL ABSORBENT TOWEL1985-12-27
K854759 — AMERICAN STERILE MAYO STAND TRAY1985-12-17
K832826 — AAP DOSIMETRY RELEASE OR BASIN SETS1984-04-23
K830546 — DOSIMETRIC RELEASE1983-05-25
K822990 — CONVERTORS PRIMARY WOUND DRESSING II1983-04-12

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.