510(k) K993017 ยท FMF Syringe, Piston
PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE
| Applicant | Shinchang Medical Co., Ltd., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Feb 25, 2000 |
| Received | Sep 8, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993017
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2018 | Cypress Medical Products LLC McKesson Insulin Syringe 0.3mL 31GX5/16
Item Numbers: 102-SN310C31516P
Product Usage:
Indication of Use: Injection of U-100 insulin only. Terminated |
FMF | None listed |
| Aug 24, 2018 | ShinChang Medical Co., Ltd. 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 Terminated |
FMF | None listed |
| Dec 28, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100 28 Gauge, 1/2cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6995-21. The device is intended to be used as an insulin Terminated |
FMF | None listed |
| Dec 28, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100 28 Gauge, 1cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6996-21 Terminated |
FMF | None listed |
| Dec 28, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100 29 Gauge, 1/2cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6997-21 Terminated |
FMF | None listed |
| Dec 28, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100 29 Gauge, 1cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6998-21 Terminated |
FMF | None listed |
| Dec 28, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100 30 Gauge, 1/2cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6999-21 Terminated |
FMF | None listed |
| Dec 28, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100 30 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7000-21 Terminated |
FMF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.