510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OWRClass II

Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery

21 CFR 878.3300 / General, Plastic Surgery
FDA source (opens on fda.gov)

OWR is the FDA product code for Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery, a class II device type, regulated under 21 CFR 878.3300. FDA's definition for this code reads: "For reinforcement of soft tissue where weakness exists in facial plastic surgery". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OWR
Device name
Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery
FDA definition
For reinforcement of soft tissue where weakness exists in facial plastic surgery.
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code OWR

By decision year
1 clearance under product code OWR with a decision year between 2023 and 2023, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OWR by decision year
YearClearances
20231

Applicants with the most clearances

Product code OWR
Applicants holding the most 510(k) clearances under product code OWR
ApplicantClearances
Shanghai Suokang Medical Implants Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code