Company ยท US
Sarstedt, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2023. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 1 |
| FPA | Set, Administration, Intravascular | 1 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 |
| JSM | Culture Media, Non-Propagating Transport | 1 |
| KHE | Reagent, Occult Blood | 1 |
| PJE | Blood/Plasma Collection Device For Dna Testing | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 25, 2023 | K222801 | Safety Lancet Sarstedt AG & CO KG, DE | FMK |
| Jul 25, 2005 | K051019 | SAFETY NEEDLE Sarstedt, Inc. | JKA |
| Sep 12, 2003 | K032150 | SAFETY-MULTIFLY Sarstedt, Inc. | FPA |
| Sep 12, 2003 | K031359 | S-MONOVETTE EDTA K2-GEL Sarstedt, Inc. | PJE |
| Apr 14, 2003 | K024237 | URINE MONOVETTE BORIC ACID Sarstedt, Inc. | JSM |
| Mar 30, 2001 | K003382 | SARSTEDT NEEDLE PROTECTOR Sarstedt, Inc. | FMI |
| Jan 31, 1992 | K913622 | HEMOPLUS Sarstedt, Inc. | KHE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2008 | Sarstedt Inc Safety Lancet for capillary blood sampling, 1.6 mm x 28G, Mini, Sarstedt. (Blood lancet) Terminated |
FMK | None listed |