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FDA 510(k)

Biodesign Staple Line Reinforcement

K-Number: K170945 · 2017-04-28

Decision Date2017-04-28
Product CodeOXE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Biodesign Staple Line Reinforcement is the device name listed in this FDA 510(k) record. The listed applicant is Cook Biotech Incorporated. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K170945. The device is classified under product code OXE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biodesign Staple Line Reinforcement?

Biodesign Staple Line Reinforcement is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Cook Biotech Incorporated. The 510(k) number is K170945.

When did Biodesign Staple Line Reinforcement receive FDA 510(k) clearance?

Biodesign Staple Line Reinforcement received FDA 510(k) clearance on 2017-04-28, under 510(k) number K170945.

Who is the listed applicant for Biodesign Staple Line Reinforcement?

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

What is the FDA product code for Biodesign Staple Line Reinforcement?

The FDA product code for Biodesign Staple Line Reinforcement is OXE.

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.

Other records listing Cook Biotech Incorporated 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.

View all 13 devices →

Related Devices (Code: OXE)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.