4 SURE TM ANESTHESIA EXTENSION SET— 510(k) K924995

Name: FDA 510(k) clearance K924995
Creator: U.S. Food and Drug Administration
Published: 1992-12-30

Substantially Equivalent

Boston Pacific Medical, Inc.

FDA 510(k) clearance K924995 for 4 SURE TM ANESTHESIA EXTENSION SET, Substantially Equivalent on 1992-12-30. Applicant: Boston Pacific Medical, Inc.. Device class: 2.

Clearance details

Applicant: Boston Pacific Medical, Inc.
Product code: Code BSO
Device class: Class 2
Regulation: 21 CFR 868.5120
Advisory panel: Anesthesiology
Date received: 1992-10-01
Decision date: 1992-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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K931047 — 4-SURE FEMALE CATHETER1994-02-14
K931048 — 4-SURE NELATON CATHETER1994-02-14
K921852 — 4 SURE TM RECTAL TUBE1993-10-08

Adverse events under product code BSO

product code BSO

Malfunction: 688
Total: 688

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.