510(k) K082114
K082114 is an FDA 510(k) premarket notification submitted by Apollo Endosurgery, Inc. for the device "ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00". The FDA issued a decision of Substantially Equivalent on December 19, 2008. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Apollo Endosurgery, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2008
- Date Received
- July 28, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Device Class
- Class II
- Regulation Number
- 876.4300
- Review Panel
- GU
- Submission Type