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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 a medical device manufactured by Standard Bariatrics, Inc.. It received FDA 510(k) clearance on 2023-10-06 under approval 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. It is manufactured by Standard Bariatrics, Inc.. The 510(k) number is K231603.

When was Standard Staple-Line Reinforcement (SSLR23) approved by the FDA?

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

What company makes Standard Staple-Line Reinforcement (SSLR23)?

Standard Staple-Line Reinforcement (SSLR23) is manufactured by Standard Bariatrics, Inc..

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

NCT07204925 Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Group 1 RECRUITING NCT07339020 Cyanoacrylate Versus Omentum for Staple-Line Reinforcement in Sleeve Gastrectomy COMPLETED NCT07123675 AI-Assisted Blood Pressure Control During Anesthesia NOT_YET_RECRUITING NCT06464978 Stapler Reinforcement Patches Compared to Standard Staplers in Gastrojejunostomy RECRUITING

Other Devices by Standard Bariatrics, Inc.

K222085Standard Tapered Bougie, 38 Fr.

Related Devices (Code: OXC)

K181940GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementW. L. Gore & Associates, Inc. K190937Echelon Endopath Staple Line ReinforcementEthicon Endo-Surgery, LLC K221343ECHELON ENDOPATH Staple Line ReinforcementEthicon Endo-Surgery, LLC K221487NEOVEIL Staple Line ReinforcementGunze Limited K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)Ethicon Endo-Surgery, LLC

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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