FDA 510(k) clearance · back to tracker

GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women

Convatec Limited cleared K252943 on 2026-04-01, decision: substantially equivalent

K-number

K252943

Sponsor

Convatec Limited

Device

GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-04-01

Product code

EZD

Advisory committee

Gastroenterology, Urology

Medical specialty

Gastroenterology, Urology

Regulation number

876.5130

Official FDA record

Open K252943on 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.

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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.

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Source

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