AUXILIARY TRAY— 510(k) K802088

Name: FDA 510(k) clearance K802088
Creator: U.S. Food and Drug Administration
Published: 1980-11-28

Substantially Equivalent

American Pharmaseal Div. Ahsc

FDA 510(k) clearance K802088 for AUXILIARY TRAY, Substantially Equivalent on 1980-11-28. Applicant: American Pharmaseal Div. Ahsc. Device class: 1.

Clearance details

Applicant: American Pharmaseal Div. Ahsc
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1980-09-02
Decision date: 1980-11-28
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 Pharmaseal Div. Ahsc

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K874022 — PHARMASEAL WOUND IRRIGATION DEVICE1987-12-30
K874045 — PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER1987-12-03
K874517 — PHARMASEAL RUBBER URETHRAL CATHETER1987-12-03
K873359 — AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE1987-11-06
K872228 — PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM1987-09-04

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.