Soft Tissue Biopsy Device
FDA 510(k) K882013 · Ocean Medical Products, Ltd.
510(k) numberK882013
Submission
- Device name
- Soft Tissue Biopsy Device
- Applicant
- Ocean Medical Products, Ltd.
Wyoming, MI, US - Received
- May 13, 1988
- Decision date
- June 15, 1988
- 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 |
| 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 |
|---|---|---|
| K870896 | Notch-Needle, Wescott StyleGAA · Traditional | 03/18/1987SE |
| K843719 | Single Wall Introducer NeedleDYB · Traditional | 10/18/1984SE |
| K823693 | Myelography NeedleFMI · Traditional | 02/07/1983SE |
| K823692 | Spinal NeedleBSP · Traditional | 01/07/1983SE |
| K813462 | Madayag Type NeedleKNW · Traditional | 03/01/1982SE |
| K813460 | Chiba Skinny NeedleGAA · Traditional | 01/07/1982SE |
| K813448 | Potts-Cournand Style NeedleGAA · Traditional | 01/07/1982SE |
| K813461 | Percutaneous Entry Needle, SeldingerDRE · Traditional | 12/29/1981SE |
Questions and answers
When was Soft Tissue Biopsy Device cleared by the FDA?
Soft Tissue Biopsy Device (K882013) received a 510(k) decision of Substantially Equivalent on June 15, 1988, 33 days after the submission was received.
What is the product code of K882013?
The FDA product code is DWO – Needle, Biopsy, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 878.4800.