PassAssist LED Light Fiber
FDA 510(k) K152435 · Entellus Medical, Inc.
510(k) numberK152435
Submission
- Device name
- PassAssist LED Light Fiber
- Applicant
- Entellus Medical, Inc.
Plymouth, MN, US - Received
- August 27, 2015
- Decision date
- November 20, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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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 |
| 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 |
| K133563 | Pathassist Light SeekerLRC · Special | 12/20/2013SE |
| 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 PassAssist LED Light Fiber cleared by the FDA?
PassAssist LED Light Fiber (K152435) received a 510(k) decision of Substantially Equivalent on November 20, 2015, 85 days after the submission was received.
What is the product code of K152435?
The FDA product code is LRC – Instrument, Ent Manual Surgical, a Class I (low risk) device regulated under 21 CFR 874.4420.