K962032 is an FDA 510(k) clearance for the KARL STORZ TWIN TRANSILLUMINATOR. This device is classified as a Transilluminator, Fiber Optic (Class I - General Controls, product code MQW).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on July 5, 1996, 42 days after receiving the submission on May 24, 1996.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4350.
| 510(k) Number | K962032 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 1996 |
| Decision Date | July 05, 1996 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | MQW — Transilluminator, Fiber Optic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4350 |