K946332 is an FDA 510(k) clearance for the KARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATION. This device is classified as a Bur, Ear, Nose And Throat (Class I - General Controls, product code EQJ).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on June 5, 1995, 158 days after receiving the submission on December 29, 1994.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4140.
| 510(k) Number | K946332 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 1994 |
| Decision Date | June 05, 1995 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EQJ — Bur, Ear, Nose And Throat |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4140 |