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FDA 510(k)

Tisuthes e-PTFE Surgical Patch

K-Number: K201153 · 2023-06-13

ApplicantShanghai Suokang Medical Implants Co., Ltd.
Decision Date2023-06-13
Product CodeOWR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Tisuthes e-PTFE Surgical Patch is a medical device manufactured by Shanghai Suokang Medical Implants Co., Ltd.. It received FDA 510(k) clearance on 2023-06-13 under approval number K201153. The device is classified under product code OWR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tisuthes e-PTFE Surgical Patch?

Tisuthes e-PTFE Surgical Patch is a medical device that received FDA 510(k) clearance on 2023-06-13. It is manufactured by Shanghai Suokang Medical Implants Co., Ltd.. The 510(k) number is K201153.

When was Tisuthes e-PTFE Surgical Patch approved by the FDA?

Tisuthes e-PTFE Surgical Patch received FDA 510(k) clearance on 2023-06-13, under approval number K201153.

What company makes Tisuthes e-PTFE Surgical Patch?

Tisuthes e-PTFE Surgical Patch is manufactured by Shanghai Suokang Medical Implants Co., Ltd..

What is the FDA product code for Tisuthes e-PTFE Surgical Patch?

The FDA product code for Tisuthes e-PTFE Surgical Patch is OWR.

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.

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