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 |
|---|---|---|---|
| B382SD77550140 | Surgical Direct | Surgical Direct, Inc. | 2026-07-14 |
| B382SD918174150 | Surgical Direct | Surgical Direct, Inc. | 2026-07-13 |
| B382SD9183701030 | Surgical Direct | Surgical Direct, Inc. | 2026-07-13 |
| B382SD484690 | Surgical Direct | Surgical Direct, Inc. | 2026-07-09 |
| B382SD9147091620 | Surgical Direct | Surgical Direct, Inc. | 2026-07-09 |
| B382SD484720 | Surgical Direct | Surgical Direct, Inc. | 2026-07-09 |
| B382SD484710 | Surgical Direct | Surgical Direct, Inc. | 2026-07-09 |
| B382SD484700 | Surgical Direct | Surgical Direct, Inc. | 2026-07-09 |
| B382SD484680 | Surgical Direct | Surgical Direct, Inc. | 2026-07-09 |
| B382SD484670 | Surgical Direct | Surgical Direct, Inc. | 2026-07-09 |
| B382SD484660 | Surgical Direct | Surgical Direct, Inc. | 2026-07-09 |
| B382SD484650 | Surgical Direct | Surgical Direct, Inc. | 2026-07-09 |
| B382SD484640 | Surgical Direct | Surgical Direct, Inc. | 2026-07-09 |
| B382SD484630 | Surgical Direct | Surgical Direct, Inc. | 2026-07-09 |
| B382SD484610 | Surgical Direct | Surgical Direct, Inc. | 2026-07-09 |
| 09348811114068 | INKA | The Trustee for KAISER FAMILY TRUST | 2026-05-29 |
| 09348811114075 | INKA | The Trustee for KAISER FAMILY TRUST | 2026-05-29 |
| B382SD915097010 | Surgical Direct | Surgical Direct, Inc. | 2026-02-09 |
| 09348811023612 | INKA | The Trustee for KAISER FAMILY TRUST | 2025-11-19 |
| 07898506813698 | Quinelato | Schobell Industrial Ltda | 2022-12-16 |
| B382SD907632000 | Surgical Direct | Surgical Direct, Inc. | 2022-12-02 |
| B382SD9228621010 | Surgical Direct | Surgical Direct, Inc. | 2022-12-01 |
| 00192896094710 | INGE LAMINA SPREADER RETRACTOR | SONTEC INSTRUMENTS, INC. | 2019-03-07 |
| 10381780024866 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780182740 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780182771 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780182788 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780182795 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780182801 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780182818 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |