Kerecis SurgiBind (50241)— 510(k) K251844

Substantially Equivalent

Kerecis Limited

FDA 510(k) clearance K251844 for Kerecis SurgiBind (50241), Substantially Equivalent on 2025-07-15. Applicant: Kerecis Limited. Device class: 2.

Clearance details

Applicant: Kerecis Limited
Product code: Code OXH
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2025-06-16
Decision date: 2025-07-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Isafjordur, IS

Download summary PDF View on FDA.gov ↗

Recent devices under product code OXH

K202430 — Kerecis Reconstruct2021-05-02
K171357 — SurgiMend PRS Meshed, Revize-X2017-06-07
K160400 — Miromatrix Biological Mesh2016-06-08
K150341 — Miromatrix Biological Mesh RS2015-05-12

More clearances from Kerecis Limited

K251845 — Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus2025-07-16
K243843 — Tendon Protect (50242)2025-06-04
K241080 — Kerecis Parvus (50207)2024-08-21
K213231 — Kerecis Silicone2022-06-29
K192612 — Kerecis Gingiva Graft2020-11-13

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