Acclarent Pivot
ACCLARENT PIVOT Navigation Balloon Dilation System - 1PK
3manufacturers in China registered for this device type
2catalogue numbers in this listing
8510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
Record
| Listed by | Acclarent, Inc., United States |
|---|---|
| FDA product code | PGW |
| Device type | Ear, Nose, And Throat Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K201115 |
| Record published | 2020-10-01 |
| Record revised | 2024-11-21 (version 3) |
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 |
|---|---|---|
| PVT0616NZ | In distribution | |
| PVT0616N | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ear, Nose, And Throat Stereotaxic Instrument | Karl Storz GmbH & Co. KG | 17 |
| StealthStation | Medtronic Navigation, Inc. | 17 |
| Medtronic Navigation | Medtronic Navigation, Inc. | 14 |
| Ear, Nose, And Throat Stereotaxic Instrument | Medtronic Navigation, Inc. | 13 |
| Ear, Nose, And Throat Stereotaxic Instrument | Stryker Leibinger Gmbh & Co. KG | 12 |
| StealthStation Cranial Software | Medtronic Navigation, Inc. | 11 |
| AxiEM™ | Medtronic Navigation, Inc. | 10 |
| Profess | Stryker Leibinger Gmbh & Co. KG | 8 |
| TGS | Stryker GmbH | 6 |
| StealthStation S8 | Medtronic Navigation, Inc. | 5 |
| TruDi Probe | Acclarent, Inc. | 4 |
| TruDi Shaver Blade | Acclarent, Inc. | 4 |
Showing 12 of 94. All products under Ear, Nose, And Throat Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231862 | 2023-07-21 |
| K221037 | 2022-07-20 |
| K201174 | 2020-08-12 |
| K193453 | 2020-03-23 |
| K190532 | 2019-05-03 |
| K180948 | 2018-07-20 |
| K173628 | 2018-03-10 |
| K161697 | 2016-10-24 |
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-09-21 | Class II | Software Design Change | When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical procedures of the Ear Nose and Throat (ENT) and ENT s | 141 |
| 2021-11-12 | Class II | Process control | Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the surgeon does not detect the accuracy error, this could lead to | 1543 |
| 2019-03-06 | Class II | Device Design | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. | |
| 2019-03-06 | Class II | Device Design | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. | |
| 2019-03-06 | Class II | Device Design | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. | 14 Suction Insstruments |
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.