The following data is part of a premarket notification filed by Smiths Medical Md, Inc. with the FDA for Gripper Micro Blunt Cannula, Non-coring Safety Needle (gripper Micro Needle) Model: 21-3253-24, 21-3258-24, 21-3262-24,.
| Device ID | K101180 |
| 510k Number | K101180 |
| Device Name: | GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24, |
| Classification | Set, Administration, Intravascular |
| Applicant | SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Saint Paul |
| Correspondent | Saint Paul SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-27 |
| Decision Date | 2010-08-03 |
| Summary: | summary |