Breast & Foreign Body Localization Instrument
FDA 510(k) K845038 · Ranfac, Corp.
510(k) numberK845038
Submission
- Device name
- Breast & Foreign Body Localization Instrument
- Applicant
- Ranfac, Corp.
Avon, MA, US - Received
- December 27, 1984
- Decision date
- March 11, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K945124 | Breast Lesion Localization NeedleGDF · Traditional | Promex, Inc. | 11/22/1994SE |
| 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 |
More from Bip USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K223612 | Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)KNW · Special | 02/21/2023SE |
| K202287 | Ran-Flex-B Bone Marrow Aspiration NeedleKNW · Traditional | 09/18/2020SE |
| K190177 | J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,KNW · Special | 06/12/2019SE |
| K183146 | Ranfac Cartilage Biopsy NeedleKNW · Traditional | 04/25/2019SE |
| K162932 | Ranfac Fat Aspiration CannulaMUU · Traditional | 01/19/2017SE |
| K150156 | Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration…MUU · Traditional | 10/19/2015SE |
| K150563 | Marrow Cellution Bone Marrow Aspiration NeedleKNW · Traditional | 05/22/2015SE |
| K140991 | Ranfac Aspiration Needle with Adjustable GuideKNW · Traditional | 09/11/2014SE |
| K131157 | Ranfac Bone Marrow Aspiration NeedleKNW · Traditional | 10/22/2013SE |
| K031344 | Ranfac Goldenberg Snarecoil Soft Tissue Biopsy (GSS) NeedleKNW · Traditional | 05/23/2003SE |
Questions and answers
When was Breast & Foreign Body Localization Instrument cleared by the FDA?
Breast & Foreign Body Localization Instrument (K845038) received a 510(k) decision of Substantially Equivalent on March 11, 1985, 74 days after the submission was received.
What is the product code of K845038?
The FDA product code is GDF – Guide, Needle, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.