Medsurg Greene Needle
FDA 510(k) K885145 · Medsurg Industries, Inc.
510(k) numberK885145
Submission
- Device name
- Medsurg Greene Needle
- Applicant
- Medsurg Industries, Inc.
Herndon, VA, US - Received
- December 15, 1988
- Decision date
- March 14, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K933364 | Promed Biopsy NeedleDWO · Traditional | Vlv Associates, Inc. | 02/15/1994SE |
| 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 |
| 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 |
More from CIVCO Medical Instruments Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K920780 | Medsurg Insertion TrayLFJ · Traditional | 08/19/1994SEKD |
| K940175 | Medsurg Sterile O.R. TowelsKKX · Traditional | 05/26/1994SE |
| K934731 | Medsurg Sterile Imaging ProductsFMP · Traditional | 03/28/1994SE |
| K925558 | InfiltubeHIF · Traditional | 03/04/1994SE |
| K934971 | Sterile Laparotomy SpongesGDY · Traditional | 02/07/1994SE |
| K920421 | Medsurg Marshmallow TrayGAT · Traditional | 12/13/1993SESK |
| K920838 | Medsurg Circumcision TrayHFK · Traditional | 10/15/1993SE |
| K931932 | Dressing Change Tray-ModifiedMCY · Traditional | 08/27/1993SEKD |
| K914037 | Medsurg O.R. Procedure TrayLRO · Traditional | 06/22/1993SEKD |
| K914036 | Medsurg Laparoscopy TrayLRO · Traditional | 03/18/1992SE |
Questions and answers
When was Medsurg Greene Needle cleared by the FDA?
Medsurg Greene Needle (K885145) received a 510(k) decision of Substantially Equivalent on March 14, 1989, 89 days after the submission was received.
What is the product code of K885145?
The FDA product code is DWO – Needle, Biopsy, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 878.4800.