OviTex PRS (Long Term Resorbable)— 510(k) K214070

Name: FDA 510(k) clearance K214070
Creator: U.S. Food and Drug Administration
Published: 2023-03-21

Substantially Equivalent

Tela Bio

FDA 510(k) clearance K214070 for OviTex PRS (Long Term Resorbable), Substantially Equivalent on 2023-03-21. Applicant: Tela Bio. Device class: 2.

Clearance details

Applicant: Tela Bio
Product code: Code FTM
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2021-12-27
Decision date: 2023-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FTM

view all

K262406 — EluPro Antibiotic-Eluting BioEnvelope2026-08-12
K250598 — Endoform Reconstructive Template - PLGA2025-06-03
K243595 — OviTex PRS (Long-Term Resorbable)2024-12-19
K233991 — CanGaroo RM Antibacterial Envelope2024-06-14
K241126 — OviTex PRS2024-05-22

Adverse events under product code FTM

product code FTM

Death: 17
Injury: 2,174
Total: 2,191

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.