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FDA 510(k)

RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747)

K-Number: K261982 · 2026-10-23

ApplicantSmith & Nephew Medical, Ltd.
Decision Date2026-10-23
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747) is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical, Ltd.. It received FDA 510(k) clearance on 2026-10-23 under 510(k) number K261982. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747)?

RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747) is a medical device that received FDA 510(k) clearance on 2026-10-23. The listed applicant is Smith & Nephew Medical, Ltd.. The 510(k) number is K261982.

When did RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747) receive FDA 510(k) clearance?

RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747) received FDA 510(k) clearance on 2026-10-23, under 510(k) number K261982.

Who is the listed applicant for RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747)?

The FDA 510(k) record lists Smith & Nephew Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747)?

The FDA product code for RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747) is OMP.

Related Clinical Trials

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Other records listing Smith & Nephew Medical, Ltd. as applicant

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Related Devices (Code: OMP)

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.

K260426MeCare Alpha (MCA2019)IVT Medical, Ltd.K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical

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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