The following data is part of a premarket notification filed by Covidien Llc, Formerly Registered As Tyco Healthca with the FDA for Idrive System (i Drive Power Handle, Idrive (ralc) Single Use Reload).
| Device ID | K102325 |
| 510k Number | K102325 |
| Device Name: | IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD) |
| Classification | Staple, Implantable |
| Applicant | COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCA 60 Middletown Ave North Haven, CT 06473 |
| Contact | Nishith Desai |
| Correspondent | Nishith Desai COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCA 60 Middletown Ave North Haven, CT 06473 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-17 |
| Decision Date | 2010-10-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884523007169 | K102325 | 000 |
| 10884523007138 | K102325 | 000 |
| 10884523007121 | K102325 | 000 |
| 10884523007145 | K102325 | 000 |
| 10884521143692 | K102325 | 000 |
| 10884523007107 | K102325 | 000 |