510(k) K010213
K010213 is an FDA 510(k) premarket notification submitted by Uromed Corp. for the device "MODIFICATION TO CAVERMAP SURGICAL AID". The FDA issued a decision of Substantially Equivalent on Apr 20, 2001. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Uromed Corp. has 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 20, 2001
- Date Received
- Jan 23, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve
- Device Class
- Class II
- Regulation Number
- 874.1820
- Review Panel
- EN
- Submission Type
- 510(k)