Ranfac Cut Biopsy Needle
FDA 510(k) K864139 · Ranfac, Corp.
510(k) numberK864139
Submission
- Device name
- Ranfac Cut Biopsy Needle
- Applicant
- Ranfac, Corp.
Avon, MA, US - Received
- October 22, 1986
- Decision date
- November 5, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GAA – Needle, Aspiration And Injection, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GAA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K223625 | CapnoSpot Pneumothorax Decompression IndicatorGAA · Traditional | Pneumeric, Inc. | 03/28/2023SE |
| K102274 | Arvik Laparoscopic Aspiration InstrumentGAA · Traditional | Arvik Enterprises/ Mini Lap Technologies | 06/15/2011SE |
| K011586 | Irma SL Blood Analysis System GL CartridgeGAA · Traditional | Diametrics Medical, Inc. | 11/16/2001SE |
| K994151 | Percutx-Injection/Aspiration Needle Probes/DevicesGAA · Traditional | Ximed/Prosure/Injectx | 03/01/2000SE |
| K983200 | Injection/Aspiration Needles Probes/Devices-Tpi/Tpi FlexGAA · Traditional | Ximed/Prosure/Injectx | 12/11/1998SE |
| K974741 | Manan Accura NeedleGAA · Traditional | Medical Device Technologies, Inc. | 01/08/1998SE |
| K962425 | Bonopty Coaxial Bone Biopsy System with Eccentric DRILL(10-1072,3,4)GAA · Traditional | Radi Medical Systems AB | 09/11/1996SE |
| K961959 | MD Tech Biopsy Set for Bone and Bone MarrowGAA · Traditional | Medical Device Technologies, Inc. | 07/19/1996SE |
| K945109 | Monoject Bone Marrow Biopsy TraysGAA · Traditional | Sherwood Medical Co. | 11/14/1994SE |
| K940025 | Manan Bone Marrow Harvest NeedlesGAA · Traditional | Manan Medical Products, Inc. | 02/25/1994SE |
More from Manan Medical Products, 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 Ranfac Cut Biopsy Needle cleared by the FDA?
Ranfac Cut Biopsy Needle (K864139) received a 510(k) decision of Substantially Equivalent on November 5, 1986, 14 days after the submission was received.
What is the product code of K864139?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.