STERILE LACERATION TRAY CAT. #749— 510(k) K900479

Name: FDA 510(k) clearance K900479
Creator: U.S. Food and Drug Administration
Published: 1990-02-13

Substantially Equivalent

Busse Hospital Disposables, Inc.

FDA 510(k) clearance K900479 for STERILE LACERATION TRAY CAT. #749, Substantially Equivalent on 1990-02-13. Applicant: Busse Hospital Disposables, Inc.. Device class: 1.

Clearance details

Applicant: Busse Hospital Disposables, Inc.
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1990-02-01
Decision date: 1990-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hauppauge, NY, US

Download summary PDF View on FDA.gov ↗

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K912106 — ARTHROSCOPY TRAY1991-08-29
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K120002 — I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE2012-06-26
K093909 — BUSSE SURGICAL DRAPES IV2010-05-06
K092212 — BUSSE SURGICAL DRAPES III2009-10-09
K082297 — BUSSE SURGICAL DRAPE2008-12-09
K073222 — MODIFICATION TO:SPECIALTY NEEDLES2008-04-09

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.