DEVICE CLASS
Class II
REGULATION
21 CFR 876.5130
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
GU
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
17
510(K)/PMA CLEARANCES
510k: 17
0
RECALL ENTRIES
Recent clearances
K261658Wellspect AB · 510k2026-07-17
K262045Coloplast A.S. · 510k2026-07-07
K260394Hangzhou Jimushi Meditech Co., Ltd. · 510k2026-06-24
K253295Hollister Incorporated · 510k2026-05-18
K260999Wellspect AB · 510k2026-04-24
K252943Convatec Limited · 510k2026-04-01
K260502HR Healthcare · 510k2026-03-12
K251274HR Healthcare · 510k2026-01-29
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.