Microendoscope
510(k) K063078
Microendoscope is a medical device (FDA Class II; FDA product code EOB, Nasopharyngoscope (Flexible Or Rigid)) made by Acclarent, Inc., cleared under FDA 510(k) K063078 on 24 Oct 2006, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063078 | Date24 Oct 2006 | StatusActive |
Official records
- FDA 510(k) database K063078
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EOB
- Device class
- Class II
- Regulation
- 21 CFR Part 874.4760
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
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