PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE
FDA 510(k) clearance K063755 · decided 2007-02-27
Clearance details
- K-number
- K063755
- Device name
- PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE
- Applicant
- Smiths Medical Asd, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-12-19
- Decision date
- 2007-02-27
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- MEG
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Keene, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13 recall (Z-1798-2021) | Smiths Medical ASD Inc. | 2021-06-10 |
| Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 i recall (Z-0642-2014) | Smiths Medical ASD, Inc. | 2014-01-08 |
| Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2 i recall (Z-0643-2014) | Smiths Medical ASD, Inc. | 2014-01-08 |
| Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 i recall (Z-0644-2014) | Smiths Medical ASD, Inc. | 2014-01-08 |
| Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 i recall (Z-0645-2014) | Smiths Medical ASD, Inc. | 2014-01-08 |
| Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 i recall (Z-0646-2014) | Smiths Medical ASD, Inc. | 2014-01-08 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S018) | Smiths Medical Asd, Inc. | 2013-05-13 |
| PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S017) | Smiths Medical Asd, Inc. | 2010-04-21 |
| PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S016) | Smiths Medical Asd, Inc. | 2009-04-20 |
| PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S015) | Smiths Medical Asd, Inc. | 2007-11-06 |
| PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S014) | Smiths Medical Asd, Inc. | 2007-08-28 |
| PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S013) | Smiths Medical Asd, Inc. | 2007-04-05 |
| PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM (P900052/S012) | Smiths Medical Asd, Inc. | 2002-12-17 |
| PORT-A-CATH EPIDURAL/PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S011) | Smiths Medical Asd, Inc. | 2002-10-03 |