Retractor, Self-Retaining
The Self-Retaining Retractor is a surgical instrument designed to hold tissue or organs out of the operative field during gastrointestinal or urological surgery without requiring continuous manual force from the surgeon. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is FFO, regulated under 21 CFR 876.4730, within the Gastroenterology, Urology medical specialty.
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Basic Information
- Product Code
- FFO
- Device Class
- FDA class 1
- Regulation Number
- 876.4730
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K993544 | SPACE-OR RETRACTOR | Dec 22, 1999 | Substantially Equivalent | Advanced Surgical Concepts (Asc) |
| K870897 | KODNER ANAL PERIONEAL RETRACTOR | Jun 04, 1987 | Substantially Equivalent | Sur-Med Instruments, Inc. |
| K860368 | URDYN 5000 (UROFLOWMETER) | Apr 23, 1986 | Substantially Equivalent | Dantec Electronics, Inc. |
| K853119 | URODYN 1000 | Oct 04, 1985 | Substantially Equivalent | Dantec Electronics, Inc. |
| K852083 | THE KENDALL URINARY OUTPUT MONITOR | Sep 20, 1985 | Substantially Equivalent | The Kendal Co. |
FEI Numbers
This FDA classification entry is associated with 150 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 150 registration numbers. Click on an entry to view related FDA registrations.