FHF · System, Evacuator, Fluid
Gastroenterology, Urology · 21 CFR 876.4370 · Class 2
Overview
| Product Code | FHF |
|---|---|
| Device Name | System, Evacuator, Fluid |
| Regulation | 21 CFR 876.4370 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
A gastroenterology-urology evacuator is a device used to remove debris and fluids during gastroenterological and urological procedures by drainage, aspiration, or irrigation. This generic type of device includes the fluid evacuator system, manually powered bladder evacuator, and the AC-powered vacuum pump.
Classification Rationale
(1) Class II (special controls) for the gastroenterology-urology evacuator when other than manually powered. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2) Class I for the gastroenterology-urology evacuator when manually powered. The device subject to this paragraph (b)(2) is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
Special Controls
*Classification.* (1) Class II (special controls) for the gastroenterology-urology evacuator when other than manually powered. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2) Class I for the gastroenterology-urology evacuator when manually powered. The device subject to this paragraph (b)(2) is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K093479 | DISPOSABLE SUCTION AND IRRIGATION SYSTEM | Modern Medical Equipment Mfg., Ltd. | May 19, 2010 | SESE |
| K003443 | SUCTION IRRIGATOR | Applied Medical | Feb 1, 2001 | SESE |
| K771986 | CATHETER, MEDIASTINAL&PERICARDIAL | The Minnesota Back Brace Co. | Oct 28, 1977 | SESE |
Top Applicants
- The Minnesota Back Brace Co. — 1 clearance
- Modern Medical Equipment Mfg., Ltd. — 1 clearance
- Applied Medical — 1 clearance
