FDA.report

510(k) K253024

Device
ProZip Knotless Implant
Applicant
Riverpoint Medical
510(k) number
K253024
Product code
GAT
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-16
Date received
2025-09-19
Regulation
878.5000
Classification name
Suture, Nonabsorbable, Synthetic, Polyethylene
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Bianca Silva de Sousa
Address
825 NE 25th Ave. Portland OR US 97232 97232

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code GAT

510(k)DeviceApplicantDecision date
K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC2026-05-06
K254275HyperSuture All Green Extension LineThreadstone, LLC2026-03-23
K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.2026-02-19
K253145Pre-Sutured TendonRti Surgical, Inc.2025-10-22
K252225PowerKnot High Strength SuturesMedacta International S.A.2025-09-12
K252201HS FiberRiverpoint Medical2025-08-13
K242201HyperSuture White/Green Extension LineThreadstone, LLC2025-03-27
K241376HyperSuture All Blue Extension LineThreadstone, LLC2024-08-09
K234079HyperSuture Extension LineThreadstone, LLC2024-05-10
K231163HS Fiber SuturesRiverpoint Medical2024-01-05
K230311HyperSutureThreadstone, LLC2023-11-24
K231183Non absorbable Surgical Polyester SutureShandong Haidike Medical Products Co., Ltd.2023-08-25
K223500SuperBall Meniscal Repair SystemArcuro Medical , Ltd.2023-08-10
K223122MENIX®; MENIX® DUOS.B.M. Sas (Science & Bio Materials)2023-08-03
K230510MyEllevateCynosure, LLC2023-07-06