NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH.— 510(k) K896321

Name: FDA 510(k) clearance K896321
Creator: U.S. Food and Drug Administration
Published: 1989-11-13

Substantially Equivalent

Superior Healthcare Group, Inc.

FDA 510(k) clearance K896321 for NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH., Substantially Equivalent on 1989-11-13. Applicant: Superior Healthcare Group, Inc.. Device class: 1.

Clearance details

Applicant: Superior Healthcare Group, Inc.
Product code: Code BSY
Device class: Class 1
Regulation: 21 CFR 868.6810
Advisory panel: Anesthesiology
Date received: 1989-11-01
Decision date: 1989-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cumberland, RI, US

Download summary PDF View on FDA.gov ↗

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K903347 — SODIUM CHLORIDE SOLUTION1990-12-13
K904216 — STERILE WATER SOLUTION CATALOG # 100001990-11-16

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.