Product code OXH— General, Plastic Surgery

Kerecis Reconstruct

Classification name: Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Total cleared: 5
First cleared: 2015-05-12
Most recent: 2025-07-15

FDA classification definition

“For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.”
— U.S. Food and Drug Administration, device classification record for product code OXH under 21 CFR 878.3300, via openFDA

Market context for product code OXH

FDA has cleared 5 devices under product code OXH between 2015 and 2025, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20251 clearance
20211 clearance
20171 clearance
20161 clearance
20151 clearance

Top applicants under product code OXH

Miromatrix Medical, Inc.2 clearances
Kerecis Limited2 clearances
Integra Lifesciences Corporation (Owner of Tei Biosciences)1 clearance

Recent clearances under product code OXH

K251844 — Kerecis SurgiBind (50241)Kerecis Limited·2025-07-15
K202430 — Kerecis ReconstructKerecis Limited·2021-05-02
K171357 — SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)·2017-06-07
K160400 — Miromatrix Biological MeshMiromatrix Medical, Inc.·2016-06-08
K150341 — Miromatrix Biological Mesh RSMiromatrix Medical, Inc.·2015-05-12

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