Pathassist Light Seeker
FDA 510(k) K133563 · Entellus Medical, Inc.
510(k) numberK133563
Submission
- Device name
- Pathassist Light Seeker
- Applicant
- Entellus Medical, Inc.
Plymouth, MN, US - Received
- November 20, 2013
- Decision date
- December 20, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LRC – Instrument, Ent Manual Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Specialty
- Ear, Nose, Throat
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| K212774 | VenSure LightGuideLRC · Traditional | Intersect Ent. | 02/04/2022SE |
| K201398 | SINUSPRIME Dilation SystemLRC · Traditional | Stryker Ent | 10/15/2020SE |
| K201115 | Next Generation Balloon Dilation SystemLRC · Traditional | Acclarent, Inc. | 08/27/2020SE |
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| K181546 | Dillard Nasal Balloon CatheterLRC · Traditional | Intuit Medical Products, LLC | 01/03/2020SE |
| K190525 | RELIEVA ULTIRRA Sinus Balloon CatheterLRC · Traditional | Acclarent, Inc. | 05/03/2019SE |
| K181838 | Sinusway Dilation SystemLRC · Traditional | 3nt Medical , Ltd. | 12/20/2018SE |
| K172737 | MESIRE - Balloon Sinus Dilatation SystemLRC · Traditional | M/S. Meril Life Sciences Private Limited | 12/12/2017SE |
| K171687 | Relieva SpinPlus Nav Balloon Sinuplasty SystemLRC · Traditional | Acclarent, Inc. | 09/05/2017SE |
More from Acclarent, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K220027 | Audion ET dilation systemPNZ · Traditional | 04/12/2022SE |
| K163509 | XprESS ENT Dilation SystemPNZ · Traditional | 04/05/2017SE |
| K163435 | Entellus Medical Reinforced Anesthesia NeedleBSP · Traditional | 04/05/2017SE |
| K152435 | PassAssist LED Light FiberLRC · Traditional | 11/20/2015SE |
| K152434 | XprESS Multi-Sinus Dilation SystemLRC · Traditional | 11/20/2015SE |
| K142252 | XprESS Multi-Sinus Dilation ToolLRC · Special | 10/17/2014SE |
| K141916 | Pathassist LED Light FiberLRC · Special | 08/07/2014SE |
| K132440 | Xpress Multi-Sinus Dilation ToolLRC · Special | 10/04/2013SE |
| K130503 | Pathassist LED Light FiberLRC · Traditional | 06/11/2013SE |
| K121943 | Xpress Multi-Sinus Dilation ToolLRC · Special | 08/22/2012SE |
Questions and answers
When was Pathassist Light Seeker cleared by the FDA?
Pathassist Light Seeker (K133563) received a 510(k) decision of Substantially Equivalent on December 20, 2013, 30 days after the submission was received.
What is the product code of K133563?
The FDA product code is LRC – Instrument, Ent Manual Surgical, a Class I (low risk) device regulated under 21 CFR 874.4420.