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FDA 510(k)

WEGO-PGLA RAPID

K-Number: K183001 · 2019-01-28

ApplicantFoosin Medical Supplies Inc., Ltd.
Decision Date2019-01-28
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WEGO-PGLA RAPID is the device name listed in this FDA 510(k) record. The listed applicant is Foosin Medical Supplies Inc., Ltd.. It received FDA 510(k) clearance on 2019-01-28 under 510(k) number K183001. 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 WEGO-PGLA RAPID?

WEGO-PGLA RAPID is a medical device that received FDA 510(k) clearance on 2019-01-28. The listed applicant is Foosin Medical Supplies Inc., Ltd.. The 510(k) number is K183001.

When did WEGO-PGLA RAPID receive FDA 510(k) clearance?

WEGO-PGLA RAPID received FDA 510(k) clearance on 2019-01-28, under 510(k) number K183001.

Who is the listed applicant for WEGO-PGLA RAPID?

The FDA 510(k) record lists Foosin Medical Supplies Inc., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WEGO-PGLA RAPID?

The FDA product code for WEGO-PGLA RAPID is GAM.

Other records listing Foosin Medical Supplies Inc., Ltd. 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.

K201139WEGO-PDO Barbed SutureK193209Wego-Stainless SteelK183004WEGO-PGA RAPIDK170842WEGO-PTFE

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

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

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