Relieva Spinplus NAV
RELIEVA SPINPLUS NAV provides access, balloon dilation and irrigation within the paranasal sinus spaces during diagnostic and therapeutic procedures. For patients aged 17 years and younger,…
RELIEVA SPINPLUS NAV provides access, balloon dilation and irrigation within the paranasal sinus spaces during diagnostic and therapeutic procedures. For patients aged 17 years and younger, dilation and irrigation are limited to the maxillary sinus. The system integrates a handle, flexible balloon catheter and sinus-navigation guidewire.
Handle controls advance, retract and rotate the guidewire and move the balloon catheter into the target ostium or outflow tract. A suction line can clear fluid or blood from the field. The balloon guard protects the balloon during guide-tip exchanges.
Listed Item
Relieva Spinplus NAV Balloon Sinuplasty System, 6X16MM, 3 Guide KIT
Navigation and Guide Tips
The package includes three sinus guide-catheter tips. An integrated connector links the device to the Acclarent ENT Navigation System, allowing electromagnetic confirmation of location relative to a preloaded scan. The balloon has a 16 mm length, and the guidewire diameter is 0.035 inches.
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Shenzhen Insighters Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Elite Medtek(Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Jiangsu Yongle Medical Technology Co., Ltd. | Taixing | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Acclarent, Inc., United States |
|---|---|
| FDA product code | LRC |
| Device type | Instrument, Ent Manual Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K171687 |
| Record published | 2018-02-18 |
| Record revised | 2026-01-12 (version 9) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in a cool, dry place |
| Packaging | Box of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RSP0616MFSN | In distribution | |
| RSP0516MFSN | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrument, Ent Manual Surgical | Karl Storz GmbH & Co. KG | 2,062 |
| Fentex | Fentex medical GmbH | 1,738 |
| Elmed | Elmed, Inc. | 504 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 441 |
| Evonos | Gyrus Acmi, Inc. | 291 |
| Millennium | Avalign Technologies, Inc. | 283 |
| Elmed Incorporated | Elmed, Inc. | 277 |
| Instrument, Ent Manual Surgical | Stryker Leibinger Gmbh & Co. KG | 169 |
| Rhinoforce | Karl Storz GmbH & Co. KG | 112 |
| Surtex | Surtex Instruments Ltd | 85 |
| Kerrison sphenoid punch | Spiggle & Theis Medizintechnik Gmbh | 82 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 78 |
Showing 12 of 661. All products under Instrument, Ent Manual Surgical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201115 | 2020-08-27 |
| K190525 | 2019-05-03 |
| K171687 | 2017-09-05 |
| K161698 | 2016-10-24 |
| K153341 | 2016-02-12 |
| K143541 | 2015-04-22 |
| K150172 | 2015-04-07 |
| K140160 | 2014-02-20 |
| K120280 | 2012-11-05 |
| K111875 | 2011-10-11 |
| K111254 | 2011-08-22 |
| K061903 | 2006-08-18 |
| K052198 | 2005-08-31 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2006-01-20 | Not classified | Other | Device sterility may be compromised as evidenced by a loss of package integrity. | 149 units | 2006-05-11 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.