K921088 is an FDA 510(k) clearance for the EVACUATOR, GASTRO-UROLOGY. This device is classified as a Evacuator, Gastro-urology (Class II — Special Controls, product code KQT).
Submitted by Northgate Technologies, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on October 28, 1992, 236 days after receiving the submission on March 6, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4370.
| 510(k) Number | K921088 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 1992 |
| Decision Date | October 28, 1992 |
| Days to Decision | 236 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KQT — Evacuator, Gastro-urology |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4370 |