The following data is part of a premarket notification filed by Terumo Europe N.v. with the FDA for Surguard3 Safety Hypodermic Needle.
| Device ID | K212095 |
| 510k Number | K212095 |
| Device Name: | SurGuard3 Safety Hypodermic Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Terumo Europe N.V. Interleuvenlaan 40 Leuven, BE 3001 |
| Contact | L. Decoster |
| Correspondent | L. Decoster Terumo Europe N.V. Interleuvenlaan 40 Leuven, BE 3001 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-06 |
| Decision Date | 2022-08-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35413206222477 | K212095 | 000 |
| 35413206222460 | K212095 | 000 |
| 35413206222453 | K212095 | 000 |
| 35413206222446 | K212095 | 000 |