ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00
FDA 510(k) clearance K082114 · decided 2008-12-19
Clearance details
- K-number
- K082114
- Device name
- ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00
- Applicant
- Apollo Endosurgery, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-07-28
- Decision date
- 2008-12-19
- Days to decision
- 144 days
- Clearance type
- Traditional
- Product code
- KNS
- Device class
- 2
- Regulation number
- 876.4300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.