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Tephaflex Surgical Mesh

FDA 510(k)

Class II (US FDA 510(k))

510(k) K070894

by Tepha, Inc.

Identifiers

510(k) Number
K070894 FDA 510(k)
FDA Product Code
OOD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.3300 FDA 510(k)
Regulation Number
878.3300 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Tephaflex Surgical Mesh is an absorbable surgical mesh classified as a surgical film under FDA product code OOD. Composed of poly-4-hydroxybutyrate (P4HB), it provides temporary wound support and reinforcement for soft tissues, hernias, or fascial defects. Its design is intended to offer structural integrity during tissue healing while being gradually absorbed by the body over time.

This device is supplied sterile and intended for single-use in clinical settings such as general and plastic surgery. It is regulated under FDA regulation 878.3300 and received a Substantially Equivalent (SESE) clearance via 510(k) submission K070894 in 2007. Available in multiple sizes (as referenced by FEI numbers), it is used in procedures like pelvic floor reconstruction and prolapse repair, adhering to standard surgical sterility and handling protocols.

Frequently asked questions

What is Tephaflex Surgical Mesh used for?

Tephaflex Surgical Mesh is an absorbable surgical film made from poly-4-hydroxybutyrate (P4HB), intended to provide temporary structural support during the healing of soft tissues, hernias, or fascial defects. It is specifically designed for procedures like pelvic floor reconstruction and prolapse repair, offering reinforcement while the body’s natural healing processes take over. The mesh gradually absorbs over time, eliminating the need for long-term implant retention.

How is Tephaflex Surgical Mesh supplied and what are its sterility and usage guidelines?

Tephaflex Surgical Mesh is supplied sterile and is intended exclusively for single-use in clinical settings. It adheres to standard surgical sterility protocols, meaning it is packaged and sterilized to ensure safety for one-time use per procedure. After use, it should be disposed of appropriately as medical waste, as reuse is not recommended or supported by the manufacturer.

What sizes or models are available for Tephaflex Surgical Mesh?

Tephaflex Surgical Mesh is available in multiple sizes, each identified by a unique FEI (Federal Equipment Identifier) number. The following FEI numbers correspond to different models: 3003521774, 3009337401, 3005636544, 3009514842, 1213643, 3005670760, 3006082230, 3030794712, 3006174295, 1000120505, 3010187263, and 3010383847. These variations allow clinicians to select the appropriate size for specific surgical applications, such as hernia repair or pelvic reconstruction.

How should Tephaflex Surgical Mesh be stored before use?

Tephaflex Surgical Mesh should be stored in its original, sealed packaging to maintain sterility until the time of use. It must be kept in a clean, dry environment, protected from moisture, extreme temperatures, and direct sunlight. The packaging should not be opened or tampered with prior to surgery to prevent contamination. Always follow the manufacturer’s storage instructions provided on the packaging to ensure optimal performance and safety.

Is Tephaflex Surgical Mesh regulated by the FDA, and what is its regulatory classification?

Yes, Tephaflex Surgical Mesh is regulated by the FDA and falls under product code OOD as a surgical film. It received a Substantially Equivalent (SESE) clearance via a 510(k) submission (K070894) in 2007, under FDA regulation 878.3300. This classification indicates that the device is deemed equivalent to a legally marketed predicate device, ensuring it meets FDA standards for safety and effectiveness in its intended use for soft tissue reinforcement.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TEPHAFLEX SURGICAL MESH by TEPHA, INC. | FDA 510 (k) Summary, TEPHAFLEX SURGICAL MESH (K070894) — FDA 510(k) | Innolitics, TEPHAFLEX SURGICAL MESH 510 (k) K070894 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Tepha, Inc.

Sources (1)

  • FDA 510(k) K070894 24 fields · synced Oct 1, 2026