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FDA 510(k)

SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE

K-Number: K990088 · 1999-02-10

ApplicantAesculap, Inc.
Decision Date1999-02-10
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 1999-02-10 under 510(k) number K990088. 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 SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE?

SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE is a medical device that received FDA 510(k) clearance on 1999-02-10. The listed applicant is Aesculap, Inc.. The 510(k) number is K990088.

When did SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE receive FDA 510(k) clearance?

SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE received FDA 510(k) clearance on 1999-02-10, under 510(k) number K990088.

Who is the listed applicant for SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE?

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

What is the FDA product code for SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE?

The FDA product code for SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE is GAT.

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Other records listing Aesculap, Inc. as applicant

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Related Devices (Code: GAT)

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K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.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.

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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