System, Evacuator, Fluid
The Fluid Evacuator System is a device used to remove irrigating fluid and debris from the operative field during urological or gastrointestinal procedures, maintaining a clear surgical field. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is FHF, regulated under 21 CFR 876.4370, within the Gastroenterology, Urology medical specialty.
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Basic Information
- Product Code
- FHF
- Device Class
- FDA class 2
- Regulation Number
- 876.4370
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K093479 | DISPOSABLE SUCTION AND IRRIGATION SYSTEM | May 19, 2010 | Substantially Equivalent | Modern Medical Equipment Mfg., Ltd. |
| K003443 | SUCTION IRRIGATOR | Feb 01, 2001 | Substantially Equivalent | Applied Medical |
| K771986 | CATHETER, MEDIASTINAL&PERICARDIAL | Oct 28, 1977 | Substantially Equivalent | The Minnesota Back Brace Co. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.