Clamp, Non-Electrical
The Non-Electrical Clamp is a manual surgical instrument used during gastrointestinal or urological procedures to occlude, compress, or stabilize tissue or vessels without the use of electrical current. It is classified as FDA Class 1, the lowest risk tier, subject only to general controls with no premarket notification required. The product code is FFN, regulated under 21 CFR 876.4730, within the Gastroenterology, Urology medical specialty.
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Basic Information
- Product Code
- FFN
- 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 |
|---|---|---|---|---|
| K932408 | AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS | Sep 28, 1993 | Substantially Equivalent | Baxter Healthcare Corp |
| K892550 | BEST COLON CLAMP | May 09, 1989 | Substantially Equivalent | Zinnanti Surgical Instruments, Inc. |
| K892542 | RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU | May 09, 1989 | Substantially Equivalent | Zinnanti Surgical Instruments, Inc. |
| K772405 | TUBING CLAMP | Jan 26, 1978 | Substantially Equivalent | Fred Sammons, Inc. |
| K771421 | CATHETEO CLAMP | Oct 25, 1977 | Substantially Equivalent | Quinton, Inc. |
FEI Numbers
This FDA classification entry is associated with 58 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 58 registration numbers. Click on an entry to view related FDA registrations.