K931731 is an FDA 510(k) clearance for the STORZ M824 FIXATION DEVICE FOR RETRACTIVE SURGERY. This device is classified as a Device, Fixation, Ac-powered, Ophthalmic (Class I - General Controls, product code HPL).
Submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on August 29, 1994, 509 days after receiving the submission on April 7, 1993.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1290. A Fixation Device Is An Ac-powered Device Intended For Use As A Fixation Target For The Patient During Ophthalmologic Examination. The Patient Directs His Or Her Gaze So That The Visual Image Of The Object Falls On The Fovea Centralis (the Center Of The Macular Retina Of The Eye.).
| 510(k) Number | K931731 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 1993 |
| Decision Date | August 29, 1994 |
| Days to Decision | 509 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HPL — Device, Fixation, Ac-powered, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1290 |
| Definition | A Fixation Device Is An Ac-powered Device Intended For Use As A Fixation Target For The Patient During Ophthalmologic Examination. The Patient Directs His Or Her Gaze So That The Visual Image Of The Object Falls On The Fovea Centralis (the Center Of The Macular Retina Of The Eye.) |