510(k) K001328
K001328 is an FDA 510(k) premarket notification submitted by Novasys Medical, Inc. for the device "INTRODUCER SHEATH". The FDA issued a decision of Substantially Equivalent on July 17, 2000. The device falls under product code FEC (Obturator, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Novasys Medical, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2000
- Date Received
- April 26, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Obturator, For Endoscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type