PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE— 510(k) K993017
Substantially EquivalentShinchang Medical Co., Ltd.
FDA 510(k) clearance K993017 for PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE, Substantially Equivalent on 2000-02-25. Applicant: Shinchang Medical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shinchang Medical Co., Ltd.
- Product code
- Code FMF
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Recent devices under product code FMF
view allMore clearances from Shinchang Medical Co., Ltd.
view allAdverse events under product code FMF
product code FMF- Death
- 15
- Injury
- 2,263
- Malfunction
- 29,722
- Other
- 17
- Total
- 32,017
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K993017
K-number listed on FDA's recall record- Z-0119-2019 — McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.
- Z-3202-2018 — Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16. (10 syringes are packaged in a flexible plastic (poly bag) and 10 flexible plastic (poly bag) are packaged in one in box. Finally, pack the inboxes in the carton case.)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K993017.
Data sourced from openFDA. This site is unofficial and independent of the FDA.