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FDA 510(k)

MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE

K-Number: K010672 · 2001-05-18

ApplicantGramsmed, LLC
Decision Date2001-05-18
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Gramsmed, LLC. It received FDA 510(k) clearance on 2001-05-18 under 510(k) number K010672. 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 MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE?

MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE is a medical device that received FDA 510(k) clearance on 2001-05-18. The listed applicant is Gramsmed, LLC. The 510(k) number is K010672.

When did MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE receive FDA 510(k) clearance?

MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE received FDA 510(k) clearance on 2001-05-18, under 510(k) number K010672.

Who is the listed applicant for MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE?

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

What is the FDA product code for MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE?

The FDA product code for MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE is GAM.

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Other records listing Gramsmed, LLC 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.

K021043GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMICK003017GRAMSORB SYNTHETIC ABSORBABLE SUTUREK003590GRAMS POLYESTER NONABSORBABLE SUTUREK002999GRAMS POLYPROPYLENE NONABSORBABLE SUTUREK003000GRAMS NYLON NONABSORBABLE SUTUREK003001GRAMS SILK NONABSORBABLE SUTURE

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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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