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FDA 510(k)

EXPANDED BODY SUTURE

K-Number: K961025 · 1996-04-15

ApplicantMedicinelodge, Inc.
Decision Date1996-04-15
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

EXPANDED BODY SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Medicinelodge, Inc.. It received FDA 510(k) clearance on 1996-04-15 under 510(k) number K961025. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the EXPANDED BODY SUTURE?

EXPANDED BODY SUTURE is a medical device that received FDA 510(k) clearance on 1996-04-15. The listed applicant is Medicinelodge, Inc.. The 510(k) number is K961025.

When did EXPANDED BODY SUTURE receive FDA 510(k) clearance?

EXPANDED BODY SUTURE received FDA 510(k) clearance on 1996-04-15, under 510(k) number K961025.

Who is the listed applicant for EXPANDED BODY SUTURE?

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

What is the FDA product code for EXPANDED BODY SUTURE?

The FDA product code for EXPANDED BODY SUTURE is GAT.

Related Clinical Trials

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.

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Other records listing Medicinelodge, Inc. 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.

K072525ZIPKNOT, MODEL 1017-3000K051488MEDICINELODGE ZIPKNOTK962705MLI MODULAR STAPLEK961920CROSS PINK961905MEDICINELODGE, INC. SET SCREWK962194MLI SOFT TISSUE SCREW & WASHER SYSTEM

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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.

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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