PATHASSIST LIGHT SEEKER
FDA 510(k) clearance K133563 · decided 2013-12-20
Clearance details
- K-number
- K133563
- Device name
- PATHASSIST LIGHT SEEKER
- Applicant
- Entellus Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-11-20
- Decision date
- 2013-12-20
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- LRC
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.