# K171687: Relieva SpinPlus Nav Balloon Sinuplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: Sep 5, 2017 after 90 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: 16 generations back to K936109 (1994). 101 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143541: Relieva SpinPlus Balloon Sinuplasty System, Acclarent, Inc. (2015) Summary page 4.
- K161697: Acclarent NavWire Sinus Navigation Guidewire, Acclarent, Inc. (2016) Summary page 4.

## Most influential descendants
- K201115: Next Generation Balloon Dilation System (2020), 0 descendants of its own

## Indications for use
The Relieva SpinPlus Nav™ Balloon Sinuplasty System is intended to provide a means to access the sinus space within and 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 Nav™ Balloon Sinuplasty System is intended to provide a means to access the sinus space, within and 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. The Relieva SpinPlus Nav™ Balloon Sinuplasty System may be utilized in conjunction with the ACCLARENT® ENT Navigation System, to provide access to nasal and sinus spaces, and to confirm placement in the accessed anatomy

Source page: https://510kreport.com/device/K171687
Methodology: https://510kreport.com/methodology