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FDA PRODUCT CODE · CLASS II

OSV — Insufflator, Endoscopic Vessel Harvesting

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 884.1730
MEDICAL SPECIALTY
Obstetrics/Gynecology
REVIEW PANEL
OB
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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