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Parker Quality & Compliance

PQC Reg Watch

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Device type

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Product code OTN · Class II · 21 CFR 878.3300 · General, Plastic Surgery

Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility

FDA classification database

Recent 510(k)s

Oct 16, 2026

K262284

KIM BLUE

Desarrollo e Investigación Médica Aragonesa S.L.

Recent recalls

No recalls in the archive for OTN.