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FDA 510(k)

HS SutureTape

K-Number: K153307 · 2016-02-12

ApplicantRiverpoint Medical
Decision Date2016-02-12
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HS SutureTape is the device name listed in this FDA 510(k) record. The listed applicant is Riverpoint Medical. It received FDA 510(k) clearance on 2016-02-12 under 510(k) number K153307. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HS SutureTape?

HS SutureTape is a medical device that received FDA 510(k) clearance on 2016-02-12. The listed applicant is Riverpoint Medical. The 510(k) number is K153307.

When did HS SutureTape receive FDA 510(k) clearance?

HS SutureTape received FDA 510(k) clearance on 2016-02-12, under 510(k) number K153307.

Who is the listed applicant for HS SutureTape?

The FDA 510(k) record lists Riverpoint Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HS SutureTape?

The FDA product code for HS SutureTape is GAT.

Other records listing Riverpoint Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253693Strut Suture; No-Tie ButtonK253695LigaMendK253024ProZip Knotless ImplantK252201HS FiberK252144Iconix Speed Anchor; Iconix Speed HA+ AnchorK243988RootMend MRR

View all 30 devices →

Related Devices (Code: GAT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, Inc.K253024ProZip Knotless ImplantRiverpoint Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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