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FDA 510(k)

MONODERM

K-Number: K040477 · 2004-05-18

ApplicantSurgical Specialties Corp
Decision Date2004-05-18
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MONODERM 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 2004-05-18 under 510(k) number K040477. 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 MONODERM?

MONODERM is a medical device that received FDA 510(k) clearance on 2004-05-18. The listed applicant is Surgical Specialties Corp. The 510(k) number is K040477.

When did MONODERM receive FDA 510(k) clearance?

MONODERM received FDA 510(k) clearance on 2004-05-18, under 510(k) number K040477.

Who is the listed applicant for MONODERM?

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 MONODERM?

The FDA product code for MONODERM is GAM.

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Other records listing Surgical Specialties Corp 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.

K080985QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO)K080680QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONEK071989QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIALK072028QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERMK063680SHARPOINT PDO (POLYDIOXANONE) SUTURESK053380CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED 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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