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FDA 510(k)

Standard Staple-Line Reinforcement (SSLR23)

K-Number: K231603 · 2023-10-06

ApplicantStandard Bariatrics, Inc.
Decision Date2023-10-06
Product CodeOXC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Standard Staple-Line Reinforcement (SSLR23) is the device name listed in this FDA 510(k) record. The listed applicant is Standard Bariatrics, Inc.. It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K231603. The device is classified under product code OXC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Standard Staple-Line Reinforcement (SSLR23)?

Standard Staple-Line Reinforcement (SSLR23) is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Standard Bariatrics, Inc.. The 510(k) number is K231603.

When did Standard Staple-Line Reinforcement (SSLR23) receive FDA 510(k) clearance?

Standard Staple-Line Reinforcement (SSLR23) received FDA 510(k) clearance on 2023-10-06, under 510(k) number K231603.

Who is the listed applicant for Standard Staple-Line Reinforcement (SSLR23)?

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

What is the FDA product code for Standard Staple-Line Reinforcement (SSLR23)?

The FDA product code for Standard Staple-Line Reinforcement (SSLR23) is OXC.

Related Clinical Trials

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NCT07339020Cyanoacrylate Versus Omentum for Staple-Line Reinforcement in Sleeve GastrectomyCOMPLETED

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Related Devices (Code: OXC)

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.

K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)Ethicon Endo-Surgery, LLCK221343ECHELON ENDOPATH Staple Line ReinforcementEthicon Endo-Surgery, LLCK221487NEOVEIL Staple Line ReinforcementGunze LimitedK190937Echelon Endopath Staple Line ReinforcementEthicon Endo-Surgery, LLCK181940GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementW. L. Gore & Associates, 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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