STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)
Device Facts
| Record ID | K954726 |
|---|---|
| Device Name | STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION) |
| Applicant | Stryker Endoscopy |
| Product Code | GCX · General Hospital |
| Decision Date | Nov 29, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6740 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
