The following data is part of a premarket notification filed by Helix Medical, Inc. with the FDA for Inhealth Soft Sleeve Colonoscope Splint, Model Cs1200.
| Device ID | K023259 |
| 510k Number | K023259 |
| Device Name: | INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | HELIX MEDICAL, INC. 1110 MARK AVE. Carpinteria, CA 93013 |
| Contact | Cynthia M Anderson |
| Correspondent | Cynthia M Anderson HELIX MEDICAL, INC. 1110 MARK AVE. Carpinteria, CA 93013 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-30 |
| Decision Date | 2002-12-26 |
| Summary: | summary |