AED RESECTOSCOPE
FDA 510(k) clearance K102663 · decided 2010-12-30
Clearance details
- K-number
- K102663
- Device name
- AED RESECTOSCOPE
- Applicant
- National Advanced Endoscopy Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-09-15
- Decision date
- 2010-12-30
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- FJL
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Canoga Park, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.