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FDA 510(k)

'cottony' II TAPE, PLEDGETS

K-Number: K153089 · 2016-08-12

ApplicantTeleflexmedical, Inc.
Decision Date2016-08-12
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

'cottony' II TAPE, PLEDGETS is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2016-08-12 under 510(k) number K153089. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 'cottony' II TAPE, PLEDGETS?

'cottony' II TAPE, PLEDGETS is a medical device that received FDA 510(k) clearance on 2016-08-12. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K153089.

When did 'cottony' II TAPE, PLEDGETS receive FDA 510(k) clearance?

'cottony' II TAPE, PLEDGETS received FDA 510(k) clearance on 2016-08-12, under 510(k) number K153089.

Who is the listed applicant for 'cottony' II TAPE, PLEDGETS?

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

What is the FDA product code for 'cottony' II TAPE, PLEDGETS?

The FDA product code for 'cottony' II TAPE, PLEDGETS is GAT.

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Related Devices (Code: GAT)

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.

K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, Inc.K253024ProZip Knotless ImplantRiverpoint Medical

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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