Breast Lesion Localization Needle
FDA 510(k) K945124 · Promex, Inc.
510(k) numberK945124
Submission
- Device name
- Breast Lesion Localization Needle
- Applicant
- Promex, Inc.
Indianapolis, IN, US - Received
- October 19, 1994
- Decision date
- November 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GDF – Guide, Needle, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GDF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K031173 | Needletech Guidewire Introducer Needle, Models 40021, 40069, 40053, 40042 & 40013GDF · Traditional | Needle Tech Products, Inc. | 07/23/2003SE |
| K950311 | Global Medical Products Brest Lesion Localization Needle with Stiffened WireGDF · Traditional | Global Medical Products, Ltd. | 05/26/1995SE |
| K950007 | Surgical Instrument GuideGDF · Traditional | United States Surgical, A Division of Tyco Healthc | 03/15/1995SE |
| K944942 | Breast Lesion Localization NeedleGDF · Traditional | Promedical , Ltd. | 11/04/1994SE |
| K935538 | Bauer Temno Coaxial NeedleGDF · Traditional | Bauer Medical, Inc. | 02/22/1994SE |
| K935457 | Localization Wire or Marker - SurgicalGDF · Traditional | Bip USA, Inc. | 02/17/1994SE |
| K923840 | Needle-GrabberGDF · Traditional | Guardian Angel Products, Inc. | 07/13/1993SE |
| K923835 | The Eleventh FingerGDF · Traditional | Guardian Angel Products, Inc. | 07/09/1993SE |
| K925875 | Horizontal Needle Guide AttachmentGDF · Traditional | Bip USA, Inc. | 04/06/1993SE |
| K924270 | Breast Lesion Localization NeedleGDF · Traditional | Core Medical, Inc. | 09/23/1992SE |
More from Core Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K023450 | Biopsy Site Tissue Marker DeviceNEU · Traditional | 12/19/2002SE |
| K022634 | Co-Axial Introducer NeedleDYB · Traditional | 11/06/2002SE |
| K010400 | Vacuum Assisted Core Biopsy DeviceKNW · Traditional | 07/24/2001SE |
| K011270 | Automated Core Biopsy DeviceFCG · Traditional | 06/22/2001SE |
| K001132 | Bone Biopsy NeedleKNW · Traditional | 05/01/2000SE |
| K994272 | Automated Core Biopsy DeviceKNW · Traditional | 01/07/2000SE |
| K993435 | Manual Bone Marrow Biopsy DeviceKNW · Traditional | 12/06/1999SE |
| K973184 | Prostate Seeding NeedleIWJ · Traditional | 11/21/1997SE |
| K972865 | Promex ENT Tissue Removal SystemERL · Traditional | 09/29/1997SE |
| K961078 | Automated Vitrectomy DeviceHQE · Traditional | 06/14/1996SE |
Questions and answers
When was Breast Lesion Localization Needle cleared by the FDA?
Breast Lesion Localization Needle (K945124) received a 510(k) decision of Substantially Equivalent on November 22, 1994, 34 days after the submission was received.
What is the product code of K945124?
The FDA product code is GDF – Guide, Needle, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.