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FDA 510(k)

Fast Absorbing PGLA

K-Number: K263073 · 2026-09-29

ApplicantRiverpoint Medical, LLC
Decision Date2026-09-29
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Fast Absorbing PGLA is the device name listed in this FDA 510(k) record. The listed applicant is Riverpoint Medical, LLC. It received FDA 510(k) clearance on 2026-09-29 under 510(k) number K263073. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fast Absorbing PGLA?

Fast Absorbing PGLA is a medical device that received FDA 510(k) clearance on 2026-09-29. The listed applicant is Riverpoint Medical, LLC. The 510(k) number is K263073.

When did Fast Absorbing PGLA receive FDA 510(k) clearance?

Fast Absorbing PGLA received FDA 510(k) clearance on 2026-09-29, under 510(k) number K263073.

Who is the listed applicant for Fast Absorbing PGLA?

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

What is the FDA product code for Fast Absorbing PGLA?

The FDA product code for Fast Absorbing PGLA is GAM.

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Other records listing Riverpoint Medical, LLC 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 ButtonK253695LigaMendK243988RootMend MRRK242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructK232411JuggerKnot Soft Anchor OCK231078All-Suture Anchor

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Related Devices (Code: GAM)

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.

K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc.K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronicK253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.K253620TroClose 1200Gordian Surgical, Ltd.K252820PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)Internacional Farmacéutica S.A DE C.V

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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