510(k) K021197 ยท FMF Syringe, Piston
SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16
| Applicant | Hosuk Co., Ltd., Minneapolis MN, US |
| Decision | Substantially Equivalent, Apr 26, 2002 |
| Received | Apr 16, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021197
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Dec 28, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100 31 Gauge, 1/2cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7001-21 Terminated |
FMF | None listed |
| Dec 28, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100 31 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7002-21 Terminated |
FMF | None listed |
| Sep 24, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100, 31Gauge, 1/2cc Insulin Syringe, 5/16" (8mm), Short Needle, NDC 0603-7001-21, packaged 10 syringes per package, 10 packages per carton Terminated |
FMF | None listed |
| Sep 24, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100, 31Gauge, 1cc Insulin Syringe, 5/16" (8mm), Short Needle, NDC 0603-7002-21, packaged 10 syringes per package, 10 packages per carton Terminated |
FMF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.