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FDA 510(k)

MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE

K-Number: K081002 · 2008-06-09

ApplicantSutures India Pvt., Ltd.
Decision Date2008-06-09
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Sutures India Pvt., Ltd.. It received FDA 510(k) clearance on 2008-06-09 under 510(k) number K081002. 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 MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE?

MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE is a medical device that received FDA 510(k) clearance on 2008-06-09. The listed applicant is Sutures India Pvt., Ltd.. The 510(k) number is K081002.

When did MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE receive FDA 510(k) clearance?

MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE received FDA 510(k) clearance on 2008-06-09, under 510(k) number K081002.

Who is the listed applicant for MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE?

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

What is the FDA product code for MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE?

The FDA product code for MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE 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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Other records listing Sutures India Pvt., 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.

K081003TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTUREK081001PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTUREK060018TRULENE MESH

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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