Cleared Traditional

K201153 - Tisuthes e-PTFE Surgical Patch (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201153 · Shanghai Suokang Medical Implants Co., Ltd. · General & Plastic Surgery device
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Jun 2023
Decision
1139d
Days
Class 2
Risk

K201153 is an FDA 510(k) clearance for the Tisuthes e-PTFE Surgical Patch. Classified as Mesh, Surgical, Non-absorbable, Facial Implants For Plastic Surgery (product code OWR), Class II - Special Controls.

Submitted by Shanghai Suokang Medical Implants Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on June 13, 2023 after a review of 1139 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Shanghai Suokang Medical Implants Co., Ltd. devices

Submission Details

510(k) Number K201153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2020
Decision Date June 13, 2023
Days to Decision 1139 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1025d slower than avg
Panel avg: 114d · This submission: 1139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWR Mesh, Surgical, Non-absorbable, Facial Implants For Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists In Facial Plastic Surgery.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.