Product code OWV— General, Plastic Surgery

DIAPHRAGMATIC HERNIA GRAFT

Classification name: Mesh, Surgical, Collagen, Diaphragmatic Hernia
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Total cleared: 1
First cleared: 2014-06-20
Most recent: 2014-06-20

FDA classification definition

“For reinforcement of soft tissue where weakness exists during diaphragmatic hernia repair.”
— U.S. Food and Drug Administration, device classification record for product code OWV under 21 CFR 878.3300, via openFDA

Market context for product code OWV

FDA has cleared 1 device under product code OWV, all in 2014, filed by 1 applicant company. 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.

Top applicants under product code OWV

Cook Biotech, Inc.1 clearance

Recent clearances under product code OWV

K133011 — DIAPHRAGMATIC HERNIA GRAFTCook Biotech, Inc.·2014-06-20

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