Needle, Aspiration And Injection, Reusable
FDA product code GDM · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
48510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Downs Surgical , Ltd. 5
- Popper & Sons, Inc. 3
- E.G. Dick & Assoc. 2
- E.L. Medico Intl., Inc. 2
- Go Medical Industries Pty. , Ltd. 2
- Bioaccess, Inc. 2
- Radiation Development Co., Inc. 2
- Angiomed U.S., Inc. 1
- Karlin Technology, Inc. 1
- T. Korossurgical Instruments Corp. 1
- Medrad, Inc. 1
- Healthtek, Inc. 1
- N-S Medical Products 1
- Gaw, Inc. 1
- Stemcor Systems, Inc. 1
- CIVCO Medical Instruments Co., Inc. 1
- Meadox Surgimed, Inc. 1
- Applied Medical Devices, Inc. 1
- Precision Dynamics Corp. 1
- A.D.T. Lab Industries 1
510(k) clearances
| 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 |
| K903749 | Islam Sternal Puncture Needle, Cat #AG-596-00-UGDM · Traditional | Downs Surgical , Ltd. | 10/31/1990SE |
| K903748 | Islam Sternal Puncture Needle, Cat # AF-594-00-VGDM · Traditional | Downs Surgical , Ltd. | 10/31/1990SE |
| K903747 | Islam Sternal Puncture Needle, Cat # AG-592-00-UGDM · Traditional | Downs Surgical , Ltd. | 10/31/1990SE |
| K902177 | Manan Bone Biopsy NeedleGDM · Traditional | Manan Medical Products, Inc. | 09/05/1990SE |
| K901995 | Pleura Biopsy DeviceGDM · Traditional | Mill-Rose Laboratory | 07/10/1990SE |
| K895752 | Diamond Blade Surgical KnivesGDM · Traditional | Magnum Diamond, Inc. | 10/17/1989SE |
| K895594 | Single Lumen O'Neil Aspiration & Irrigation NeedleGDM · Traditional | Go Medical Industries Pty. , Ltd. | 10/06/1989SE |
| K895551 | Rocket Bone Marrow NeedleGDM · Traditional | A & A Medical, Inc. | 10/06/1989SE |
| K890722 | Adg Bone Biopsy SystemGDM · Traditional | American Design Group, Inc. | 09/21/1989SE |
| K891537 | Core Biopsy Needle, Catalog Code #54006GDM · Traditional | Dlp, Inc. | 04/18/1989SE |
| K885283 | Aspirating and Irrigating Cysts NeedlesGDM · Traditional | Go Medical Industries Pty. , Ltd. | 03/22/1989SE |
| K881784 | Klein NeedleGDM · Traditional | E.L. Medico Intl., Inc. | 12/02/1988SE |
| K881783 | Klein HandleGDM · Traditional | E.L. Medico Intl., Inc. | 12/02/1988SE |
| K883876 | Williams-Fritts Pleural Biopsy NeedleGDM · Traditional | E.G. Dick & Assoc. | 10/07/1988SE |
| K881624 | Pleural Biopsy Punch NeedleGDM · Traditional | E.G. Dick & Assoc. | 08/11/1988SE |
| K882240 | Storz Univ Irrigat/Aspira & Phacoemulsifcation PacGDM · Traditional | Storz Instrument Co. | 07/29/1988SE |
| K882601 | E-Z-Em(R) Lufkin Biopsy NeedlesGDM · Traditional | E-Z-Em, Inc. | 07/25/1988SE |
| K882073 | Spinal NeedleGDM · Traditional | Karlin Technology, Inc. | 07/18/1988SE |
| K881730 | Breast Localization NeedlesGDM · Traditional | Hart Enterprises, Inc. | 05/13/1988SE |
| K880812 | Spinal NeedleGDM · Traditional | T. Korossurgical Instruments Corp. | 03/11/1988SE |
| K874928 | Wholey (TM) Biopsy DeviceGDM · Traditional | Medrad, Inc. | 12/30/1987SE |
| K873848 | Retrobulbar NeedleGDM · Traditional | Healthtek, Inc. | 10/23/1987SE |
| K870523 | Hawkins Breast Localization NeedleGDM · Traditional | N-S Medical Products | 03/09/1987SE |
| K864193 | Gilbaugh Aspirating Biopsy Syringe/Needle/GunGDM · Traditional | Gaw, Inc. | 11/17/1986SE |
| K862805 | Angiomed Vac-U-Cut Biopsy NeedleGDM · Traditional | Angiomed U.S., Inc. | 09/29/1986SE |
| K862749 | LS9000 Suction Biopsy NeedleGDM · Traditional | Engineering, Inc. | 09/15/1986SE |
| K862481 | Civco/Kempf Aspiration/Biopsy/Dialysis NeedleGDM · Traditional | CIVCO Medical Instruments Co., Inc. | 07/23/1986SE |
| K854420 | Meadox Surgimed A/S Three Piece Screw Biopsy NeedlGDM · Traditional | Meadox Surgimed, Inc. | 11/22/1985SE |
| K843830 | J -Jamshidi Type-Bone Marrow Biopsy/AspiGDM · Traditional | Popper & Sons, Inc. | 10/26/1984SE |
| K843690 | Illinois Sternum/Iliac Aspiration NeedleGDM · Traditional | Popper & Sons, Inc. | 10/25/1984SE |
| K833720 | Transthoracic/Transabdominal-TrayGDM · Traditional | Applied Medical Devices, Inc. | 05/30/1984SE |
| K841299 | Bierman Biopsy NeedleGDM · Traditional | Popper & Sons, Inc. | 05/02/1984SE |
| K830235 | Franzen Needle GuideGDM · Traditional | Precision Dynamics Corp. | 02/23/1983SE |
| K820339 | Islam Bone Marrow Biopsy NeedleGDM · Traditional | Downs Surgical , Ltd. | 02/23/1982SE |
| K800406 | Ferris Bone Marrow Biopsy-Aspir. NeedleGDM · Traditional | A.D.T. Lab Industries | 03/12/1980SE |
| K791643 | Bone Marrow NeedleGDM · Traditional | Johannah Medical Services, Inc. | 09/12/1979SE |
| K772293 | Bone Marrow Biopsy DeviceGDM · Traditional | Radiation Development Co., Inc. | 01/03/1978SE |
| K771574 | Lee Aspiration NeedleGDM · Traditional | Radiation Development Co., Inc. | 12/06/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2331-2025 Class II | Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm…Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of… | Spiggle & Theis Mt Gmbh | 06/27/2025Open, Classified |
| Z-1178-2016 Class II | Pilling Modular Verres Body/Obturator, Product Code 140880Packaging error in which customers who ordered product code 140880 (Verres cannula for use with a separately… | Teleflex Medical | 01/08/2015Terminated |
| Z-2015-2010 | Angiotech Breast Localization Needles: A) Accura BLN and Accura II BLN with Stiffening…Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast… | Medical Device Technologies, Inc. | 09/01/2009Terminated |
| Z-1417-2009 | CHIBA NEEDLE MARKED, Model CNM-1806, Size: 18 GA x 15 CM, Qty: 10 each, Remington…Incorrect needle (Franseen Needle, FNM-1806) was packaged as a Chiba Needle Marked. | Remington Medical Inc. | 04/06/2009Terminated |