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

Insufflator, Endoscopic Vessel Harvesting

21 CFR 884.1730 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

OSV is the FDA product code for Insufflator, Endoscopic Vessel Harvesting, a class II device type, regulated under 21 CFR 884.1730. FDA's definition for this code reads: "To provide selected flow rates and pressures of co2 gas to separate tissue planes so the saphenous vein or radial artery can be isolated and ligated". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OSV
Device name
Insufflator, Endoscopic Vessel Harvesting
FDA definition
To provide selected flow rates and pressures of co2 gas to separate tissue planes so the saphenous vein or radial artery can be isolated and ligated.
Regulation
21 CFR 884.1730
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order