FDA 510(k) clearance · back to tracker

GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C

Uresil, L.P. cleared K021632 on 2002-06-13, decision: substantially equivalent

K-number

K021632

Sponsor

Uresil, L.P.

Device

GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C

Class

Class I

Decision

Substantially Equivalent

Decision date

2002-06-13

Product code

GBO

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4200

Official FDA record

Open K021632on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.