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FDA 510(k)

PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT

K-Number: K100461 · 2010-07-08

ApplicantRiverpoint Medical
Decision Date2010-07-08
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT is the device name listed in this FDA 510(k) record. The listed applicant is Riverpoint Medical. It received FDA 510(k) clearance on 2010-07-08 under 510(k) number K100461. 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 PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT?

PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT is a medical device that received FDA 510(k) clearance on 2010-07-08. The listed applicant is Riverpoint Medical. The 510(k) number is K100461.

When did PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT receive FDA 510(k) clearance?

PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT received FDA 510(k) clearance on 2010-07-08, under 510(k) number K100461.

Who is the listed applicant for PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT?

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

What is the FDA product code for PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT?

The FDA product code for PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT is NEW.

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Other records listing Riverpoint Medical as applicant

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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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