Product code GWY
- Device name
- Pinwheel
- Medical specialty
- Neurology
- Device class
- 1
- Regulation number
- 882.1750
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K050313 | BIS SRS (SEMI-RESUABLE SENSOR) | Aspect Medical Systems, Inc. | 2005-02-24 |
| K942926 | NEURO-AIDE | Burke Neutech, Inc. | 1994-08-03 |
| K871167 | SENSITESTER | Dexin Pty. , Ltd. | 1987-04-01 |
| K851749 | 1-380 PINWHEEL (WARTENBERG) | Artiberia | 1985-06-13 |
| K780422 | PINWHEEL | Projects IN Health | 1978-04-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G586G5541360 | Novo Surgical | NOVO SURGICAL, INC. | 2023-12-18 |
| G586G95541360 | Novo Surgical | NOVO SURGICAL, INC. | 2023-12-18 |
| 00817524029956 | J&J Instruments | J & J INSTRUMENTS INC | 2023-06-08 |
| 00840183505394 | BR Surgical, LLC | BR Surgical, LLC | 2023-03-28 |
| 10665973022786 | Tech-Med | Dukal LLC | 2022-12-06 |
| 20665973022783 | Tech-Med | Dukal LLC | 2022-12-06 |
| B8032805140 | ORTHOMED | ORTHO-MED, INC. | 2022-09-02 |
| M368130911 | Grafco | GF HEALTH PRODUCTS, INC. | 2021-06-09 |
| 04046826046439 | Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 2020-09-24 |
| 00840314200280 | gSource | GSOURCE LLC | 2019-08-30 |
| 00612479142855 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2018-12-05 |
| 00612479141285 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2018-11-12 |
| 00192896024380 | WARTENBERG PIN WHEEL | SONTEC INSTRUMENTS, INC. | 2018-09-14 |
| 10381780357612 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-09-12 |
| H83412260 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-09-12 |
| 10885403081033 | V. Mueller | STERIS CORPORATION | 2018-08-30 |
| 10381780487333 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-08-20 |
| H834MH12260 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-08-20 |
| M2741801301 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780181484 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780414483 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-22 |
| H834V912260 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-22 |
| 00634782501815 | ADC® | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782036409 | ADC® | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782001827 | ADC® | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782536251 | ADC® | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |