510(k) K161853
K161853 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System". The FDA issued a decision of Substantially Equivalent on Feb 27, 2017. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Aesculap, Inc. has 217 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 27, 2017
- Date Received
- Jul 6, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shunt, Central Nervous System And Components
- Device Class
- Class II
- Regulation Number
- 882.5550
- Review Panel
- NE
- Submission Type
- 510(k)