Acclarent Pivot
ACCLARENT PIVOT Illumination Balloon Dilation System - 1PK
11manufacturers in China registered for this device type
2catalogue numbers in this listing
13510(k) clearances naming this product code
1recall
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) | K201115 |
| Record published | 2020-10-01 |
| Record revised | 2024-11-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 |
|---|---|---|
| PVT0616LZ | In distribution | |
| PVT0616 | 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.