PVS · Class II — Moderate Risk (510(k) clearance required) · Obstetrics/Gynecology · 21 CFR 884.1560
Classification
FDA Product Code
PVS
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 884.1560
Review panel
OB
Medical specialty
Obstetrics/Gynecology
Submission type
7
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.