K180610 is an FDA 510(k) clearance for the Geister retractor for neuro - and spine surgery. This device is classified as a Retractor, Self-retaining, For Neurosurgery (Class II - Special Controls, product code GZT).
Submitted by Geister Medizin Technik GmbH (Tuttlingen, DE). The FDA issued a Cleared decision on August 29, 2018, 174 days after receiving the submission on March 8, 2018.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 882.4800.
| 510(k) Number | K180610 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 2018 |
| Decision Date | August 29, 2018 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GZT - Retractor, Self-retaining, For Neurosurgery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4800 |