Promed Biopsy Needle
FDA 510(k) K933364 · Vlv Associates, Inc.
510(k) numberK933364
Submission
- Device name
- Promed Biopsy Needle
- Applicant
- Vlv Associates, Inc.
East Hanover, NJ, US - Received
- July 9, 1993
- Decision date
- February 15, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DWO – Needle, Biopsy, Cardiovascular
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code DWO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K921418 | Ultra-Core Biopsy NeedlesDWO · Traditional | Medical Device Technologies, Inc. | 06/19/1992SE |
| K913815 | Automated Biopsy Device, ModificationDWO · Traditional | Hart Enterprises, Inc. | 10/30/1991SE |
| K890925 | Manan Bone Marrow Biopsy NeedleDWO · Traditional | Manan Medical Products, Inc. | 04/11/1989SE |
| K885145 | Medsurg Greene NeedleDWO · Traditional | Medsurg Industries, Inc. | 03/14/1989SE |
| K885149 | Needle Insert for Soft Tissue Biopsy DeviceDWO · Traditional | Hart Enterprises, Inc. | 01/26/1989SE |
| K882013 | Soft Tissue Biopsy DeviceDWO · Traditional | Ocean Medical Products, Ltd. | 06/15/1988SE |
| K874585 | Angiomed Osty-Cut Bone Biopsy NeedleDWO · Traditional | Angiomed U.S., Inc. | 12/02/1987SE |
| K872597 | Fine Needle Aspiration Biopsy System-ProstateDWO · Traditional | Dianon Systems, Inc. | 07/28/1987SE |
| K853312 | Argon Cut Biopsy Needles, Various SizesDWO · Traditional | Argon Medical Corp. | 09/12/1985SE |
| K820269 | RNG Series Ultrasound Needle/Cath. GDSDWO · Traditional | CIVCO Medical Instruments Co., Inc. | 03/23/1982SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K972957 | Sa-Ef Multi-Lumen Extension SetFPA · Traditional | 09/29/1997SE |
| K964876 | Sa.Ef(Tm) Infusion Port II - Connector and Extension SetFPA · Traditional | 02/28/1997SE |
| K955783 | VLV Sa.Ef Infusion Port Extension SetsFPA · Traditional | 02/07/1996SE |
| K953791 | VLV SA Ef Infusion PortFPA · Traditional | 10/30/1995SE |
| K945592 | VLV Solodraw(Tm) Dual Chamber Piston SyringeFMF · Traditional | 07/14/1995SE |
| K940406 | Disposable, Ambulatory, Infusion PumpsMEB · Traditional | 09/02/1994ST |
| K922469 | Pro-Lok Extension Set(S)FPA · Traditional | 03/15/1993SE |
| K904217 | Pro-Lok (TM) Extension SetsFPA · Traditional | 10/03/1990SE |
| K901081 | Pro-Lock(Tm) Shielding Needle Connector AssemblyFPA · Traditional | 06/08/1990SE |
| K901046 | Versa-Lock(Tm) Universal Needle ConnectorFPA · Traditional | 06/08/1990SE |
Questions and answers
When was Promed Biopsy Needle cleared by the FDA?
Promed Biopsy Needle (K933364) received a 510(k) decision of Substantially Equivalent on February 15, 1994, 221 days after the submission was received.
What is the product code of K933364?
The FDA product code is DWO – Needle, Biopsy, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 878.4800.