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FDA 510(k)

MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE

K-Number: K030212 · 2003-03-27

ApplicantGenzyme Biosurgery
Decision Date2003-03-27
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Biosurgery. It received FDA 510(k) clearance on 2003-03-27 under 510(k) number K030212. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE?

MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE is a medical device that received FDA 510(k) clearance on 2003-03-27. The listed applicant is Genzyme Biosurgery. The 510(k) number is K030212.

When did MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE receive FDA 510(k) clearance?

MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE received FDA 510(k) clearance on 2003-03-27, under 510(k) number K030212.

Who is the listed applicant for MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE?

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

What is the FDA product code for MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE?

The FDA product code for MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE is NEW.

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Other records listing Genzyme Biosurgery 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.

K031554S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEMK022989RADLITE TISSUE RETRACTOR SYSTEMK022410SAPH-LOOP LIGATING LOOP

Related Devices (Code: NEW)

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.

K254238MINT MONO SuturesHans Biomed CorporationK253879MONOFIX PDOSamyang Holdings CorporationK261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLCK252171Barbed PDO SutureSutura Medical Technology, Inc.K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc.K243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.

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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