Amg + Med Lancet
K870017 is the FDA 510(k) clearance record for AMG + MED LANCET, a class II device, cleared for Can-Am Surgical Corp. on under FDA product code FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature). FDA's definition for product code FMK reads: "A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop...". FDA records list 6 510(k) clearances for Can-Am Surgical Corp., from to . As of , FDA records show no recalls naming K870017.
Clearance record
- Decision date
- Received
- (19 days to decision)
- Product code
- FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- Regulation
- 21 CFR 878.4850
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Applicant
- Can-Am Surgical Corp. 3068 Stonewood St., Simi Valley CA
- Third party review
- No
Clearances, product code FMK
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 2 |
| March 2026 | 1 |
| April 2026 | 0 |
| May 2026 | 1 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 1 |
| October 2026 | 0 |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
