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FDA 510(k)

NEATSTITCH NEATCLOSE SUTURING DEVICE

K-Number: K063462 · 2007-01-12

ApplicantNeat Stitch , Ltd.
Decision Date2007-01-12
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEATSTITCH NEATCLOSE SUTURING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Neat Stitch , Ltd.. It received FDA 510(k) clearance on 2007-01-12 under 510(k) number K063462. 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 NEATSTITCH NEATCLOSE SUTURING DEVICE?

NEATSTITCH NEATCLOSE SUTURING DEVICE is a medical device that received FDA 510(k) clearance on 2007-01-12. The listed applicant is Neat Stitch , Ltd.. The 510(k) number is K063462.

When did NEATSTITCH NEATCLOSE SUTURING DEVICE receive FDA 510(k) clearance?

NEATSTITCH NEATCLOSE SUTURING DEVICE received FDA 510(k) clearance on 2007-01-12, under 510(k) number K063462.

Who is the listed applicant for NEATSTITCH NEATCLOSE SUTURING DEVICE?

The FDA 510(k) record lists Neat Stitch , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEATSTITCH NEATCLOSE SUTURING DEVICE?

The FDA product code for NEATSTITCH NEATCLOSE SUTURING DEVICE is GAM.

Related Clinical Trials

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.

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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

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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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