WOUND CLOSURE INSTRUMENT TRAY— 510(k) K812133

Name: FDA 510(k) clearance K812133
Creator: U.S. Food and Drug Administration
Published: 1982-01-08

Substantially Equivalent

E.M. Adams

FDA 510(k) clearance K812133 for WOUND CLOSURE INSTRUMENT TRAY, Substantially Equivalent on 1982-01-08. Applicant: E.M. Adams. Device class: 1.

Clearance details

Applicant: E.M. Adams
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1981-07-28
Decision date: 1982-01-08
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 E.M. Adams

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K905173 — SPLASH GUARD1991-04-25
K910468 — STERILE DISPOSABLE DRAPE(S)1991-03-21
K873978 — DISPOSABLE BIPOLAR FORCEPS1987-11-23
K850063 — INSTRUMENT POCKET1985-02-21
K843724 — I.V. START KIT & OBSTETRICAL KIT1985-01-10

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.