FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PATHASSIST LIGHT SEEKER
K Number: K133563
·
Decision Dec 20, 2013
Classifications
1
FEI Numbers
223
Registration Numbers
223
Same Product Code
64
Applicant Total
27
Review Days
30
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Basic Information
- Device Name
- PATHASSIST LIGHT SEEKER
- K Number
- K133563
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Entellus Medical, Inc.
- Date Received
- November 20, 2013
- Decision Date
- December 20, 2013
- Product Code
- LRC
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LRC | Instrument, Ent Manual Surgical | FDA class 1 | Ear, Nose, Throat |
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Other Clearances by Entellus Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K220027 | Audion ET dilation system | Apr 12, 2022 | Substantially Equivalent |
| K163509 | XprESS ENT Dilation System | Apr 5, 2017 | Substantially Equivalent |
| K163435 | Entellus Medical Reinforced Anesthesia Needle | Apr 5, 2017 | Substantially Equivalent |
| K152435 | PassAssist LED Light Fiber | Nov 20, 2015 | Substantially Equivalent |
| K152434 | XprESS Multi-Sinus Dilation System | Nov 20, 2015 | Substantially Equivalent |
| K142252 | XprESS Multi-Sinus Dilation Tool | Oct 17, 2014 | Substantially Equivalent |
| K141916 | PATHASSIST LED LIGHT FIBER | Aug 7, 2014 | Substantially Equivalent |
| K132440 | XPRESS MULTI-SINUS DILATION TOOL | Oct 4, 2013 | Substantially Equivalent |
| K130503 | PATHASSIST LED LIGHT FIBER | Jun 11, 2013 | Substantially Equivalent |
| K121943 | XPRESS MULTI-SINUS DILATION TOOL | Aug 22, 2012 | Substantially Equivalent |