Product code FFO
- Device name
- Retractor, Self-Retaining
- 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 |
|---|---|---|---|
| K993544 | SPACE-OR RETRACTOR | Advanced Surgical Concepts (Asc) | 1999-12-22 |
| K870897 | KODNER ANAL PERIONEAL RETRACTOR | Sur-Med Instruments, Inc. | 1987-06-04 |
| K860368 | URDYN 5000 (UROFLOWMETER) | Dantec Electronics, Inc. | 1986-04-23 |
| K853119 | URODYN 1000 | Dantec Electronics, Inc. | 1985-10-04 |
| K852083 | THE KENDALL URINARY OUTPUT MONITOR | The Kendal Co. | 1985-09-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B382SD460350 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD460360 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD467000 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD467010 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD467020 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD467030 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD467040 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD467050 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD48250 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD493680 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD493690 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD493770 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD6213120 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD459000 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD14174550 | Surgical Direct | Surgical Direct, Inc. | 2026-07-31 |
| 00190776407483 | Millennium | Avalign Technologies, Inc. | 2026-07-31 |
| B382SD90712216T0 | Surgical Direct | Surgical Direct, Inc. | 2026-07-29 |
| B382SD907581320 | Surgical Direct | Surgical Direct, Inc. | 2026-07-24 |
| B382SD9075041030 | Surgical Direct | Surgical Direct, Inc. | 2026-07-17 |
| B382SD907530128T0 | Surgical Direct | Surgical Direct, Inc. | 2026-07-17 |
| B382SD907530129T0 | Surgical Direct | Surgical Direct, Inc. | 2026-07-17 |
| B382SD907573330 | Surgical Direct | Surgical Direct, Inc. | 2026-07-17 |
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