BUSSE BAC/SHIELD— 510(k) K902297

Name: FDA 510(k) clearance K902297
Creator: U.S. Food and Drug Administration
Published: 1990-08-17

Substantially Equivalent

Busse Hospital Disposables, Inc.

FDA 510(k) clearance K902297 for BUSSE BAC/SHIELD, Substantially Equivalent on 1990-08-17. Applicant: Busse Hospital Disposables, Inc.. Device class: 1.

Clearance details

Applicant: Busse Hospital Disposables, Inc.
Product code: Code BSY
Device class: Class 1
Regulation: 21 CFR 868.6810
Advisory panel: Anesthesiology
Date received: 1990-05-23
Decision date: 1990-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hauppauge, NY, US

Download summary PDF View on FDA.gov ↗

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K981910 — SUCTION CATHETER1998-08-24
K972258 — HI-CARE CLOSED SUCTION SYSTEM1997-12-29

More clearances from Busse Hospital Disposables, Inc.

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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 BSY

product code BSY

Death: 3
Injury: 155
Malfunction: 959
Total: 1,117

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.