# K143541: Relieva SpinPlus Balloon Sinuplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: Apr 22, 2015 after 128 days
- Product code: LRC (Instrument, Ent Manual Surgical)
- Device class: 1
- Regulation: 21 CFR 874.4420
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K936109 (1994). 83 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111875: Relieva Spin Sinus Dilation System, Acclarent, Inc. (2011) Summary page 4.
- K111254: Relieva Solo Elite Sinus Balloon Catheter, Acclarent, Inc. (2011) Summary page 4.
- K071845: Relieva Luma Sinus Illumination System, Model Sis-100A, Acclarent, Inc. (2007) Summary page 4.

## Most influential descendants
- K171687: Relieva SpinPlus Nav Balloon Sinuplasty System (2017), 1 descendant of its own
- K201115: Next Generation Balloon Dilation System (2020), 0 descendants of its own

## Indications for use
The Relieva SpinPlus Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures; and irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures. For children aged 17 and under, the Relieva SpinPlus Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate across nasal and sinus structures; dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures; and irrigate from within the maxillary sinus for therapeutic procedures and to facilitate diagnostic procedures.

Source page: https://510kreport.com/device/K143541
Methodology: https://510kreport.com/methodology