FDA 510(k) clearance · back to tracker

MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY

Uresil, LLC cleared K041995 on 2004-08-19, decision: substantially equivalent

K-number

K041995

Sponsor

Uresil, LLC

Device

MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY

Class

Class I

Decision

Substantially Equivalent

Decision date

2004-08-19

Product code

GBO

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4200

Official FDA record

Open K041995on accessdata.fda.gov →

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

openFDA JSON

Raw record →

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

Use this as a predicate

Drop K041995 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

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