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FDA 510(k)

Holycon Synthetic Absorbable Sutures

K-Number: K173043 · 2017-12-14

ApplicantNantong Holycon Medical Devices Co., Ltd.
Decision Date2017-12-14
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Holycon Synthetic Absorbable Sutures is the device name listed in this FDA 510(k) record. The listed applicant is Nantong Holycon Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2017-12-14 under 510(k) number K173043. 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 Holycon Synthetic Absorbable Sutures?

Holycon Synthetic Absorbable Sutures is a medical device that received FDA 510(k) clearance on 2017-12-14. The listed applicant is Nantong Holycon Medical Devices Co., Ltd.. The 510(k) number is K173043.

When did Holycon Synthetic Absorbable Sutures receive FDA 510(k) clearance?

Holycon Synthetic Absorbable Sutures received FDA 510(k) clearance on 2017-12-14, under 510(k) number K173043.

Who is the listed applicant for Holycon Synthetic Absorbable Sutures?

The FDA 510(k) record lists Nantong Holycon Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Holycon Synthetic Absorbable Sutures?

The FDA product code for Holycon Synthetic Absorbable Sutures is GAM.

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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