The following data is part of a premarket notification filed by Sti Medical Systems, Llc with the FDA for Colonoscopy Assistant.
| Device ID | K102949 |
| 510k Number | K102949 |
| Device Name: | COLONOSCOPY ASSISTANT |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | STI MEDICAL SYSTEMS, LLC 99-193 AIEA HEIGHTS DRIVE Aiea, HI 96701 |
| Contact | Rolf Wolters |
| Correspondent | Rolf Wolters STI MEDICAL SYSTEMS, LLC 99-193 AIEA HEIGHTS DRIVE Aiea, HI 96701 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-05 |
| Decision Date | 2011-06-15 |
| Summary: | summary |