BREVET CASSETTE STERILIZATION MODULE— 510(k) K882617

Name: FDA 510(k) clearance K882617
Creator: U.S. Food and Drug Administration
Published: 1988-07-28

Substantially Equivalent

Brevet, Inc.

FDA 510(k) clearance K882617 for BREVET CASSETTE STERILIZATION MODULE, Substantially Equivalent on 1988-07-28. Applicant: Brevet, Inc.. Device class: 1.

Clearance details

Applicant: Brevet, Inc.
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1988-06-24
Decision date: 1988-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anahem, CA, 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 Brevet, Inc.

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K910794 — SMALL INSTRUMENT STERILIZATION/BUR BOX1991-05-23
K895958 — BREVET FLOSS PICK (AUTOCLAVE STERILIZER)1989-12-04
K895959 — BREVET FLOSS PICK (COLD STERILIZATION FLUIDS)1989-11-29
K895753 — BREVET DISPOSABLE CONNECTORS1989-11-14
K883126 — BREVET DENTAL INSTRUMENTS1988-10-05

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.