FDA 510(k)

MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE

K-Number: K052437 · 2005-11-07

Decision Date2005-11-07

Product CodeGAM

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Specialties Corp. It received FDA 510(k) clearance on 2005-11-07 under 510(k) number K052437. 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 MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE?

MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE is a medical device that received FDA 510(k) clearance on 2005-11-07. The listed applicant is Surgical Specialties Corp. The 510(k) number is K052437.

When did MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE receive FDA 510(k) clearance?

MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE received FDA 510(k) clearance on 2005-11-07, under 510(k) number K052437.

Who is the listed applicant for MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE?

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

What is the FDA product code for MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE?

The FDA product code for MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE is GAM.

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Other records listing Surgical Specialties Corp as applicant

K080985QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO)K080680QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE K071989QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL K072028QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM K063680SHARPOINT PDO (POLYDIOXANONE) SUTURES K053380CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE

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Related Devices (Code: GAM)

K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc.K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronic K253852MONOCRYL™ 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.