The following data is part of a premarket notification filed by Wilson-cook Medical Inc. with the FDA for Axcess Soft Tip Wire Guide.
| Device ID | K122816 |
| 510k Number | K122816 |
| Device Name: | AXCESS SOFT TIP WIRE GUIDE |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | WILSON-COOK MEDICAL INC. 4900 Bethania Station Rd Winston Salem, NC 27105 |
| Contact | Doris A Hawks |
| Correspondent | Doris A Hawks WILSON-COOK MEDICAL INC. 4900 Bethania Station Rd Winston Salem, NC 27105 |
| Product Code | OCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-14 |
| Decision Date | 2012-10-09 |
| Summary: | summary |