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

Mesh, Surgical, Deployer

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

ORQ is the FDA product code for Mesh, Surgical, Deployer, a class II device type, regulated under 21 CFR 878.3300. FDA's definition for this code reads: "Intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.G. Hernia repair)". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ORQ
Device name
Mesh, Surgical, Deployer
FDA definition
Intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.G. Hernia repair).
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code ORQ

By decision year
6 clearances under product code ORQ with a decision year between 2010 and 2025, 2010 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code ORQ by decision year
YearClearances
20102
20122
20131
20251

Applicants with the most clearances

Product code ORQ
Applicants holding the most 510(k) clearances under product code ORQ
ApplicantClearances
Medtronic, Inc.3
Polytouch Medical, Ltd.2
ConMed Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order