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ORQ — Mesh, Surgical, Deployer Class II

FDA Device Classification

Classification Details

Product Code
ORQ
Device Class
Class II
Regulation Number
878.3300
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

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).

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250395conmed corporationBioBrace ® RC Delivery SystemApril 7, 2025
K130782covidienACCUMESH DEPLOYMENT SYSTEMApril 5, 2013
K123066covidienACCUMESH DEPLOYMENT SYSTEMOctober 16, 2012
K121139covidienACCUMESH DEPLOYMENT SYSTEMMay 2, 2012
K103269polytouch medicalPATCHASSIST LARGENovember 23, 2010
K101218polytouch medicalPATCHASSISTJune 17, 2010