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#
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|---|---|---|---|
| 09348811114075 | INKA | The Trustee for KAISER FAMILY TRUST | 2026-05-29 |
| 09348811114068 | INKA | The Trustee for KAISER FAMILY TRUST | 2026-05-29 |
| 09348811023612 | INKA | The Trustee for KAISER FAMILY TRUST | 2025-11-19 |
| 07898506813698 | Quinelato | Schobell Industrial Ltda | 2022-12-16 |
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| 10381780268444 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | 2018-02-23 |
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