OviTex PRS

FDA 510(k) K241126 · TELA Bio, Inc.

Substantially Equivalent

510(k) numberK241126

Submission

Device name
OviTex PRS
Applicant
TELA Bio, Inc.
Malvern, PA, US
Received
April 23, 2024
Decision date
May 22, 2024
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FTM – Mesh, Surgical
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3300
Specialty
General, Plastic Surgery
Implant
Yes

Other 510(k)s with product code FTM

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K262406EluPro Antibiotic-Eluting BioEnvelopeFTM · Special Boston Scientific08/12/2026SE
K250598Endoform Reconstructive Template - PLGAFTM · Traditional Aroa Biosurgery , Ltd.06/03/2025SE
K243595OviTex PRS (Long-Term Resorbable)FTM · Special TELA Bio, Inc.12/19/2024SE
K233991CanGaroo RM Antibacterial EnvelopeFTM · Traditional Elutia, Inc.06/14/2024SE
K223052Peri-Guard and Supple Peri-GuardFTM · Traditional Synovis Life Technologies, Inc.04/07/2023SE
K214070OviTex PRS (Long Term Resorbable)FTM · Traditional Tela Bio03/21/2023SE
K213163VersaWrapFTM · Special Alafair Biosciences, Inc.10/29/2021SE
K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…FTM · Special Synovis Life Technologies. Inc. (A Subsidiary of…10/27/2021SE
K203496Nexo-Gide Bilayer Collagen MembraneFTM · Traditional Geistlich Pharma AG07/14/2021SE
K203600VersaWrapFTM · Traditional Alafair Biosciences, Inc.03/09/2021SE

More from Alafair Biosciences, Inc.

510(k)DeviceDecision
K243595OviTex PRS (Long-Term Resorbable)FTM · Special 12/19/2024SE
K214070OviTex PRS (Long Term Resorbable)FTM · Traditional 03/21/2023SE
K141053Ovine Tissue Matrix(Otm)FTM · Traditional 12/11/2014SE

Questions and answers

When was OviTex PRS cleared by the FDA?

OviTex PRS (K241126) received a 510(k) decision of Substantially Equivalent on May 22, 2024, 29 days after the submission was received.

What is the product code of K241126?

The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.