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FDA 510(k)

UNICRYL

K-Number: K042288 · 2004-12-27

ApplicantUnited Medical Industries Co. , Ltd.
Decision Date2004-12-27
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UNICRYL is the device name listed in this FDA 510(k) record. The listed applicant is United Medical Industries Co. , Ltd.. It received FDA 510(k) clearance on 2004-12-27 under 510(k) number K042288. 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 UNICRYL?

UNICRYL is a medical device that received FDA 510(k) clearance on 2004-12-27. The listed applicant is United Medical Industries Co. , Ltd.. The 510(k) number is K042288.

When did UNICRYL receive FDA 510(k) clearance?

UNICRYL received FDA 510(k) clearance on 2004-12-27, under 510(k) number K042288.

Who is the listed applicant for UNICRYL?

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

What is the FDA product code for UNICRYL?

The FDA product code for UNICRYL is GAM.

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Other records listing United Medical Industries Co. , 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.

K072646UNICAPRONEK072645UNIGLACTINK072644UNICRYL QUICKK042287UNIPLAIN & UNICHROMK042285UNICRYL MK042284UNIMIDE

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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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