Tisuthes e-PTFE Surgical Patch
K-Number: K201153 · 2023-06-13
Decision Date2023-06-13
Product CodeOWR
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Tisuthes e-PTFE Surgical Patch is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Suokang Medical Implants Co., Ltd.. It received FDA 510(k) clearance on 2023-06-13 under 510(k) 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. The listed applicant is Shanghai Suokang Medical Implants Co., Ltd.. The 510(k) number is K201153.
When did Tisuthes e-PTFE Surgical Patch receive FDA 510(k) clearance?
Tisuthes e-PTFE Surgical Patch received FDA 510(k) clearance on 2023-06-13, under 510(k) number K201153.
Who is the listed applicant for Tisuthes e-PTFE Surgical Patch?
The FDA 510(k) record lists Shanghai Suokang Medical Implants Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.