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FDA 510(k)

DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE

K-Number: K082097 · 2010-01-08

ApplicantDemetech Corp.
Decision Date2010-01-08
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Demetech Corp.. It received FDA 510(k) clearance on 2010-01-08 under 510(k) number K082097. 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 DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE?

DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE is a medical device that received FDA 510(k) clearance on 2010-01-08. The listed applicant is Demetech Corp.. The 510(k) number is K082097.

When did DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE receive FDA 510(k) clearance?

DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE received FDA 510(k) clearance on 2010-01-08, under 510(k) number K082097.

Who is the listed applicant for DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE?

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

What is the FDA product code for DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE?

The FDA product code for DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE is NEW.

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Other records listing Demetech 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.

K130083DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTUREK072930DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUTK043330POLYPROPILENE SURGICAL SUTURESK043539DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLESK023030DEMETECH POLYESTER NONABSORBABLE SUTUREK023028DEMETECH NYLON NONABSORBABLE SUTURE

View all 8 devices →

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

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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