4 SURE TM ENTERAL FEEDING BAG— 510(k) K922402

Name: FDA 510(k) clearance K922402
Creator: U.S. Food and Drug Administration
Published: 1994-03-25

Substantially Equivalent

Boston Pacific Medical, Inc.

FDA 510(k) clearance K922402 for 4 SURE TM ENTERAL FEEDING BAG, Substantially Equivalent on 1994-03-25. Applicant: Boston Pacific Medical, Inc.. Device class: 2.

Clearance details

Applicant: Boston Pacific Medical, Inc.
Product code: Code FPD
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1992-05-21
Decision date: 1994-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Boston Pacific Medical, Inc.

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K933109 — 4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS1994-03-28
K931047 — 4-SURE FEMALE CATHETER1994-02-14
K931048 — 4-SURE NELATON CATHETER1994-02-14
K921852 — 4 SURE TM RECTAL TUBE1993-10-08
K921853 — 4 SURE TM FEEDING TUBES1993-07-13

Adverse events under product code FPD

product code FPD

Death: 6
Other: 1
Total: 7

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.