Needle, Blood Collecting
FDA 510(k) K790079 · Jelco Laboratories
510(k) numberK790079
Submission
- Device name
- Needle, Blood Collecting
- Applicant
- Jelco Laboratories
Mchenry, IL, US - Received
- January 9, 1979
- Decision date
- February 1, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GAA – Needle, Aspiration And Injection, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| K011586 | Irma SL Blood Analysis System GL CartridgeGAA · Traditional | Diametrics Medical, Inc. | 11/16/2001SE |
| K994151 | Percutx-Injection/Aspiration Needle Probes/DevicesGAA · Traditional | Ximed/Prosure/Injectx | 03/01/2000SE |
| K983200 | Injection/Aspiration Needles Probes/Devices-Tpi/Tpi FlexGAA · Traditional | Ximed/Prosure/Injectx | 12/11/1998SE |
| K974741 | Manan Accura NeedleGAA · Traditional | Medical Device Technologies, Inc. | 01/08/1998SE |
| K962425 | Bonopty Coaxial Bone Biopsy System with Eccentric DRILL(10-1072,3,4)GAA · Traditional | Radi Medical Systems AB | 09/11/1996SE |
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| K940025 | Manan Bone Marrow Harvest NeedlesGAA · Traditional | Manan Medical Products, Inc. | 02/25/1994SE |
More from Manan Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K791918 | Jelco Winged Intravascular CatheterFOZ · Traditional | 10/02/1979SE |
| K791372 | Jelco & Kvo Catheter Placement UnitJCY · Traditional | 09/12/1979SE |
| K790967 | Catheter Metal Hub/RadiopaqueFOZ · Traditional | 06/27/1979SE |
| K790968 | Catheter Metal Hub/NonradiopaqueFOZ · Traditional | 06/11/1979SE |
| K790471 | Jelco* Disc FILTER-0.2 MicronFPB · Traditional | 04/30/1979SE |
| K790186 | ProtectivstabilizerGBJ · Traditional | 02/26/1979SE |
| K790107 | Catheter Tubing ModificationDQO · Traditional | 02/01/1979SE |
| K781857 | Tray, Arterial Blood Gas SamplingCBT · Traditional | 12/11/1978SE |
| K780896 | Needles, Design Change, IV CathetersGCB · Traditional | 08/23/1978SE |
| K780519 | Filter TubeBSN · Traditional | 05/09/1978SE |
Questions and answers
When was Needle, Blood Collecting cleared by the FDA?
Needle, Blood Collecting (K790079) received a 510(k) decision of Substantially Equivalent on February 1, 1979, 23 days after the submission was received.
What is the product code of K790079?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.