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FDA 510(k)

POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)

K-Number: K002190 · 2000-08-10

ApplicantCp Medical
Decision Date2000-08-10
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP) is the device name listed in this FDA 510(k) record. The listed applicant is Cp Medical. It received FDA 510(k) clearance on 2000-08-10 under 510(k) number K002190. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)?

POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP) is a medical device that received FDA 510(k) clearance on 2000-08-10. The listed applicant is Cp Medical. The 510(k) number is K002190.

When did POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP) receive FDA 510(k) clearance?

POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP) received FDA 510(k) clearance on 2000-08-10, under 510(k) number K002190.

Who is the listed applicant for POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)?

The FDA 510(k) record lists Cp Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)?

The FDA product code for POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP) 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 Cp Medical 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.

K094028CP-FIBER (ORTHOFIBER)K072229MONOSWIFTK071550PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERSK060987OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31K041894ORTHOFIBERK034062CP SLEEVE AND RIVER SLEEVE

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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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