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FDA 510(k)

TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE

K-Number: K041515 · 2005-04-08

ApplicantSutures India Private Limited
Decision Date2005-04-08
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Sutures India Private Limited. It received FDA 510(k) clearance on 2005-04-08 under 510(k) number K041515. 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 TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE?

TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE is a medical device that received FDA 510(k) clearance on 2005-04-08. The listed applicant is Sutures India Private Limited. The 510(k) number is K041515.

When did TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE receive FDA 510(k) clearance?

TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE received FDA 510(k) clearance on 2005-04-08, under 510(k) number K041515.

Who is the listed applicant for TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE?

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

What is the FDA product code for TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE?

The FDA product code for TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL 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 Private Limited 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.

K041514TRUESILK NON-ABSORBABLE SILK SURGICAL SUTUREK041511TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTUREK041512NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTUREK041510TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE

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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