Product code FFP
- Device name
- Dilator, Rectal
- Medical specialty
- Gastroenterology, Urology
- Device class
- 1
- Regulation number
- 876.5450
- 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 |
|---|---|---|---|
| K964634 | ANOKRYO | Mk Conquest Intl., Inc. | 1997-06-06 |
| K901426 | COLONIC BALLOON DILATOR | Telemed Systems, Inc. | 1990-06-21 |
| K894618 | INAMED RHEMO-D (TM) DILATOR | Inamed Development Co. | 1990-01-18 |
| K884713 | COLONIC BALLOON DIALATORS | Primrose Medical, Inc. | 1989-09-29 |
| K830354 | COLORECTAL DILATOR | Cleveland Medical Supply & Services | 1983-05-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850005838449 | Intimate Rose | PLUS EV HOLDINGS INC. | 2024-12-10 |
| 00850005838456 | Intimate Rose | PLUS EV HOLDINGS INC. | 2024-12-10 |
| 00850005838463 | Intimate Rose | PLUS EV HOLDINGS INC. | 2024-12-10 |
| 00850005838487 | Intimate Rose | PLUS EV HOLDINGS INC. | 2024-12-10 |
| 00850005838494 | Intimate Rose | PLUS EV HOLDINGS INC. | 2024-12-10 |
| 00850005838500 | Intimate Rose | PLUS EV HOLDINGS INC. | 2024-12-10 |
| 00850005838517 | Intimate Rose | PLUS EV HOLDINGS INC. | 2024-12-10 |
| 00850005838524 | Intimate Rose | PLUS EV HOLDINGS INC. | 2024-12-10 |
| 00850005838531 | Intimate Rose | PLUS EV HOLDINGS INC. | 2024-12-10 |
| 00850005838548 | Intimate Rose | PLUS EV HOLDINGS INC. | 2024-12-10 |
| 00850005838555 | Intimate Rose | PLUS EV HOLDINGS INC. | 2024-12-10 |
| G586UR96214130 | Novo Surgical | NOVO SURGICAL, INC. | 2023-12-19 |
| G586UR96214120 | Novo Surgical | NOVO SURGICAL, INC. | 2023-12-19 |
| G586UR6214140 | Novo Surgical | NOVO SURGICAL, INC. | 2023-12-19 |
| G586UR6214120 | Novo Surgical | NOVO SURGICAL, INC. | 2023-12-19 |
| G586UR6213360 | Novo Surgical | NOVO SURGICAL, INC. | 2023-12-19 |
| G586UR96214140 | Novo Surgical | NOVO SURGICAL, INC. | 2023-12-19 |
| G586UR6217130 | Novo Surgical | NOVO SURGICAL, INC. | 2023-12-18 |
| G586UR6217220 | Novo Surgical | NOVO SURGICAL, INC. | 2023-12-18 |
| G586UR6217120 | Novo Surgical | NOVO SURGICAL, INC. | 2023-12-18 |
| G586UR6217140 | Novo Surgical | NOVO SURGICAL, INC. | 2023-12-18 |
| G586UR6217150 | Novo Surgical | NOVO SURGICAL, INC. | 2023-12-18 |
| G586UR6217210 | Novo Surgical | NOVO SURGICAL, INC. | 2023-12-18 |
| G586UR6216160 | Novo Surgical | NOVO SURGICAL, INC. | 2023-12-18 |
| G586UR6216100 | Novo Surgical | NOVO SURGICAL, INC. | 2023-12-18 |
| 00842331194603 | Novo Surgical | NOVO SURGICAL, INC. | 2023-12-18 |
| 08033638801147 | Dilastom | SAPI MED SPA | 2023-08-02 |
| 08033638800362 | Dilatan Plus | SAPI MED SPA | 2023-07-27 |
| 08033638800355 | Dilatan Plus | SAPI MED SPA | 2023-07-27 |
| 20705036001314 | PROXIMATE | ETHICON ENDO-SURGERY, LLC | 2016-07-15 |