Illinois Sternum/Iliac Aspiration Needle
FDA 510(k) K843690 · Popper & Sons, Inc.
510(k) numberK843690
Submission
- Device name
- Illinois Sternum/Iliac Aspiration Needle
- Applicant
- Popper & Sons, Inc.
New Hyde Park, NY, US - Received
- September 19, 1984
- Decision date
- October 25, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GDM – Needle, Aspiration And Injection, Reusable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GDM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K071732 | MarrowminerGDM · Traditional | Stemcor Systems, Inc. | 09/24/2007SE |
| K971114 | Bioaccess Marrow Harvest SystemGDM · Traditional | Bioaccess, Inc. | 06/03/1997SE |
| K953082 | Iliac Crest Bone Marrow Aspiration NeedleGDM · Traditional | Baxter Healthcare Corp | 09/22/1995SE |
| K953064 | Bioaccess Marrow Harvest SystemGDM · Traditional | Bioaccess, Inc. | 08/07/1995SE |
| K936207 | Endo-Needle InstrumentGDM · Traditional | Gerard Medical, Inc. | 06/16/1994SE |
| K930160 | Illinois Sternal/Iliac Aspiration NeedleGDM · Traditional | Symbiosis Corp. | 07/06/1993SE |
| K923872 | Bone Marrow Biopsy SystemGDM · Traditional | The Straumann Co. | 12/15/1992SE |
| K915572 | Becton Dickinson Modified Menghini NeedleGDM · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/03/1992SE |
| K904667 | Na NeedlesGDM · Traditional | Olympus Corp. | 12/12/1990SE |
| K903750 | Islam Sternal Puncture Needle, Cat #AG-598-OO-EGDM · Traditional | Downs Surgical , Ltd. | 10/31/1990SE |
More from Downs Surgical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K911397 | Hypodermic Needles, Single LumenFCG · Traditional | 05/20/1991SE |
| K843830 | J -Jamshidi Type-Bone Marrow Biopsy/AspiGDM · Traditional | 10/26/1984SE |
| K842406 | Wescott Type Biopsy Needle · Traditional | 08/09/1984SE |
| K841301 | Gardner Type Bone Marrow NeedleGAA · Traditional | 06/05/1984SE |
| K841300 | Antrum Needle-Wolf Type · Traditional | 06/05/1984SE |
| K841299 | Bierman Biopsy NeedleGDM · Traditional | 05/02/1984SE |
| K840168 | Westerman-Jensen Biopsy NeedleFCG · Traditional | 03/12/1984SE |
Questions and answers
When was Illinois Sternum/Iliac Aspiration Needle cleared by the FDA?
Illinois Sternum/Iliac Aspiration Needle (K843690) received a 510(k) decision of Substantially Equivalent on October 25, 1984, 36 days after the submission was received.
What is the product code of K843690?
The FDA product code is GDM – Needle, Aspiration And Injection, Reusable, a Class I (low risk) device regulated under 21 CFR 878.4800.