CONVERTORS FLASH STERILIZING TRAY— 510(k) K832137

Name: FDA 510(k) clearance K832137
Creator: U.S. Food and Drug Administration
Published: 1983-08-12

Substantially Equivalent

American Convertors Div., American Pharmaseal

FDA 510(k) clearance K832137 for CONVERTORS FLASH STERILIZING TRAY, Substantially Equivalent on 1983-08-12. Applicant: American Convertors Div., American Pharmaseal. Device class: 1.

Clearance details

Applicant: American Convertors Div., American Pharmaseal
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1983-07-01
Decision date: 1983-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FSM

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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 Convertors Div., American Pharmaseal

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K830786 — DISIMETRIC RELEASE OF INSTRANETICS RAD1983-05-18
K820994 — ABSORB FURN SHEET1982-05-13
K813419 — COMFORT CUSHION DRY BURN PAD III1982-01-22
K813296 — CONVERTORS STERILE DISP. LAP SPONGE II1981-12-29

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.