K940371 is an FDA 510(k) clearance for the SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP. This device is classified as a Syringe, Irrigating (non Dental) (Class I - General Controls, product code KYZ).
Submitted by Micromedics, Inc. (Eagan, US). The FDA issued a Cleared decision on April 6, 1994, 90 days after receiving the submission on January 6, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6960.
| 510(k) Number | K940371 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 06, 1994 |
| Decision Date | April 06, 1994 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KYZ — Syringe, Irrigating (non Dental) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6960 |