510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201153Substantially Equivalent

Tisuthes e-PTFE Surgical Patch

Shanghai Suokang Medical Implants Co., Ltd., Shanghai, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201153 is the FDA 510(k) clearance record for Tisuthes e-PTFE Surgical Patch, a class II device, cleared for Shanghai Suokang Medical Implants Co., Ltd. on under FDA product code OWR (Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery). FDA's definition for product code OWR reads: "For reinforcement of soft tissue where weakness exists in facial plastic surgery". FDA records list one 510(k) clearance for Shanghai Suokang Medical Implants Co., Ltd. As of , FDA records show no recalls naming K201153.

Clearance record

Decision date
Received
(1,139 days to decision)
Product code
OWR Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Shanghai Suokang Medical Implants Co., Ltd. Bldg. 2, # 613, Suide Rd., Putuo Region, Shanghai,, Shanghai, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OWR

Trailing 12 months

FDA records hold no clearances under product code OWR in the trailing twelve months.

FDA records show no clearances under product code OWR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OWR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260