Ultra-Core Biopsy Needles
FDA 510(k) K921418 · Medical Device Technologies, Inc.
510(k) numberK921418
Submission
- Device name
- Ultra-Core Biopsy Needles
- Applicant
- Medical Device Technologies, Inc.
Gainsville, FL, US - Received
- March 24, 1992
- Decision date
- June 19, 1992
- 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 |
|---|---|---|---|
| K933364 | Promed Biopsy NeedleDWO · Traditional | Vlv Associates, Inc. | 02/15/1994SE |
| 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 |
More from CIVCO Medical Instruments Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K101832 | Biopince Ultra Full Core Biopsy InstrumentKNW · Traditional | 08/27/2010SE |
| K053518 | Interv Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorNEU · Special | 01/26/2006SE |
| K051421 | Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorNEU · Traditional | 08/30/2005SE |
| K050873 | Canalizer Hydrophilic Guide WireDQX · Traditional | 05/26/2005SE |
| K043523 | Interv Brand Snarelok Bone Marrow Biopsy NeedleKNW · Traditional | 02/11/2005SE |
| K042464 | V-Core Full Core Breast Biopsy InstrumentKNW · Traditional | 09/30/2004SE |
| K040427 | Fibrex Catheter Patency DeviceFOZ · Traditional | 05/03/2004SE |
| K031442 | PBN GuidewiresDQX · Traditional | 08/13/2003SE |
| K021606 | En-Snare Endovascular Snare and CatheterMMX · Traditional | 05/31/2002SE |
| K011790 | Microcruiser Plus Introducer SetDYB · Traditional | 09/05/2001SE |
Questions and answers
When was Ultra-Core Biopsy Needles cleared by the FDA?
Ultra-Core Biopsy Needles (K921418) received a 510(k) decision of Substantially Equivalent on June 19, 1992, 87 days after the submission was received.
What is the product code of K921418?
The FDA product code is DWO – Needle, Biopsy, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 878.4800.