Zamenix™ P

FDA 510(k) clearance K253505 · decided 2026-08-07

Clearance details

K-number: K253505
Device name: Zamenix™ P
Applicant: Roen Surgical, Inc.
Decision: Substantially Equivalent
Date received: 2025-10-31
Decision date: 2026-08-07
Days to decision: 280 days
Clearance type: Traditional
Product code: FGB
Device class: 2
Regulation number: 876.1500
Medical specialty: Gastroenterology, Urology
Advisory committee: Gastroenterology, Urology
Location: Daejeon, KR
Third-party review: No
Expedited review: No

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Recalls involving this device

No recalls on record reference this clearance.