K952008 is an FDA 510(k) clearance for the KARL STORZ DRILL. This device is classified as a Motor, Surgical Instrument, Ac-powered (Class I - General Controls, product code GEY).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on July 26, 1995, 89 days after receiving the submission on April 28, 1995.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K952008 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 1995 |
| Decision Date | July 26, 1995 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GEY — Motor, Surgical Instrument, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |