Angiomed Osty-Cut Bone Biopsy Needle
FDA 510(k) K874585 · Angiomed U.S., Inc.
510(k) numberK874585
Submission
- Device name
- Angiomed Osty-Cut Bone Biopsy Needle
- Applicant
- Angiomed U.S., Inc.
Anaheim, CA, US - Received
- November 9, 1987
- Decision date
- December 2, 1987
- 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 |
| 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 |
| 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 |
|---|---|---|
| K874771 | Angiomed Introducing SetsDWB · Traditional | 01/12/1988SE |
| K864225 | Angiomed Ureteral D&M Sets/Ureteroscopy Guid StentFAD · Traditional | 01/30/1987SE |
| K863386 | Vesico Suprapubic Bladder Drainage & Exchange SetsKOB · Traditional | 10/24/1986SE |
| K862805 | Angiomed Vac-U-Cut Biopsy NeedleGDM · Traditional | 09/29/1986SE |
| K863446 | Angiomed High Pressure ConnectorsGCD · Traditional | 09/23/1986SE |
| K854910 | AngioflowDQO · Traditional | 07/17/1986SE |
| K854912 | Angiomed Guied WiresDQX · Traditional | 04/16/1986SE |
| K854908 | UroflexFAD · Traditional | 03/14/1986SE |
| K855143 | Angiomed Exchange Drainage Catheter SetsKOD · Traditional | 03/11/1986SE |
| K855142 | Angiomed Percutaneous Transhepatic CholangiogtaphyFGE · Traditional | 03/11/1986SE |
Questions and answers
When was Angiomed Osty-Cut Bone Biopsy Needle cleared by the FDA?
Angiomed Osty-Cut Bone Biopsy Needle (K874585) received a 510(k) decision of Substantially Equivalent on December 2, 1987, 23 days after the submission was received.
What is the product code of K874585?
The FDA product code is DWO – Needle, Biopsy, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 878.4800.