K870978 is an FDA 510(k) clearance for the T-TUBE INSERTER. This device is classified as a Inserter, Myringotomy Tube (Class I - General Controls, product code JYM).
Submitted by Sur-Med Instruments, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 19, 1987, 9 days after receiving the submission on March 10, 1987.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K870978 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 1987 |
| Decision Date | March 19, 1987 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | JYM — Inserter, Myringotomy Tube |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4420 |