The following data is part of a premarket notification filed by Terumo Corp. with the FDA for Single Use Guidewire, Models G-240-2527s, G-240-2545s, G-240-2527a, G-240-2545a, G-240-3527s, G-240-3545s & G-240-3527a.
| Device ID | K091417 |
| 510k Number | K091417 |
| Device Name: | SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | TERUMO CORP. 950 Elkton Blvd. Elkton, MD 21921 |
| Contact | Mark Unterreiner |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | OCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-05-13 |
| Decision Date | 2009-05-22 |
| Summary: | summary |