Product code FGM
- Device name
- Probe And Director, Gastro-Urology
- Medical specialty
- Gastroenterology, Urology
- Device class
- 1
- Regulation number
- 876.4730
- Review panel
- GU
- 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 |
|---|---|---|---|
| K041732 | CAVERMAP SURGICAL AID | Blue Torch Medical Technologies | 2004-09-21 |
| K031527 | MODIFICATION TO CAVERMAP SURGICAL AID | Blue Torch Medical Technologies | 2003-06-05 |
| K010098 | MODIFICATION TO CAVERMAP SURGICAL AID | Uromed Corp. | 2001-02-01 |
| K993436 | CAVERMAP SURGICAL AID | Uromed Corp. | 2000-02-11 |
| K944378 | ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG | Regulatory & Marketing Services, Inc. | 1995-02-15 |
| K944379 | ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG | Regulatory & Marketing Services, Inc. | 1995-02-15 |
| K944384 | ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG | Regulatory & Marketing Services, Inc. | 1995-02-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07898506814534 | Quinelato | Schobell Industrial Ltda | 2022-12-20 |
| 07898506814541 | Quinelato | Schobell Industrial Ltda | 2022-12-20 |
| 07898506814558 | Quinelato | Schobell Industrial Ltda | 2022-12-20 |
| 07898506814565 | Quinelato | Schobell Industrial Ltda | 2022-12-20 |
| 07898506814572 | Quinelato | Schobell Industrial Ltda | 2022-12-20 |
| 07898506814633 | Quinelato | Schobell Industrial Ltda | 2022-12-20 |
| 07898506814527 | Quinelato | Schobell Industrial Ltda | 2022-12-20 |
| 10381780181545 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-03-22 |
| 10381780181552 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-03-22 |
| 10381780181569 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-09-28 |
| 10381780181583 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-09-28 |
| 10381780181576 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-09-28 |
| 10381780181538 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-09-28 |
| 10381780357865 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-28 |
| 10381780357858 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-28 |
| 10381780357841 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-28 |
| 10381780357834 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-28 |
| 10381780357827 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-28 |
| 10381780357810 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-28 |
| 10381780357803 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-28 |
| 10381780357797 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-28 |
| 10381780357780 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-28 |
| 10381780357742 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-28 |
| 10381780357735 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-28 |
| 10381780357728 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-28 |
| 10381780357711 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-28 |
| 10381780357704 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-28 |
| 10381780357698 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-28 |
| 10381780357681 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-28 |
| 10381780357674 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-28 |