RNS Sterile, Disposable Breast Biopsy/Localization Tray
FDA 510(k) K955683 · Contour Fabricators of Florida, Inc.
510(k) numberK955683
Submission
- Device name
- RNS Sterile, Disposable Breast Biopsy/Localization Tray
- Applicant
- Contour Fabricators of Florida, Inc.
Palm Harobor, FL, US - Received
- December 14, 1995
- Decision date
- February 1, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MJG – Device, Percutaneous, Biopsy
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code MJG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K080674 | Pajunk's Primocut Disposable Biopsy SystemMJG · Traditional | PAJUNK GmbH Medizintechnologie | 05/09/2008SE |
| K070836 | Exiclip Excs-MMJG · Traditional | Clevex, Inc. | 04/20/2007SE |
| K983647 | Echo-Coat Ultrasound NeedlesMJG · Traditional | Sts Biopolymers | 01/20/1999SE |
| K933324 | Skin Biopsy DeviceMJG · Traditional | Nhr, Inc. | 03/31/1994SE |
| K925870 | SpacerMJG · Traditional | Bip USA, Inc. | 05/19/1993SE |
| K922919 | Dynacyt Biopsy Aspiration DeviceMJG · Traditional | Buckman Co., Inc. | 03/31/1993SE |
More from Buckman Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K955685 | RNS Sterile, Disposable CT Biopsy TrayDXT · Traditional | 10/04/1996SE |
| K962040 | RNS Arthrogram TrayFMI · Traditional | 06/25/1996SE |
| K955687 | RNS Sterile, Disposable Radiographic Contrast TrayJAA · Traditional | 06/03/1996SE |
| K955689 | RNS Sterile, Disposable Digital Angiographic TrayDWS · Traditional | 05/15/1996SE |
| K955684 | RNS Sterile, Disposable Angiographic TrayDXT · Traditional | 05/02/1996SESK |
| K955679 | RNS Sterile, Disposable Amniocentesis TrayHIO · Traditional | 03/12/1996SE |
| K955688 | RNS Sterile, Disposable Standard Biopsy TrayFRG · Traditional | 02/21/1996SE |
| K955686 | RNS, Sterile Disposable Percutaneous Cholangiographic TrayFRG · Traditional | 02/21/1996SE |
| K955678 | RNS Sterile Disposable Puncture TrayFRG · Traditional | 02/21/1996SE |
| K952396 | Redi Nurse System (RNS) Sterile 0.9% Sodium Chloride SolutionBSY · Traditional | 08/15/1995SE |
Questions and answers
When was RNS Sterile, Disposable Breast Biopsy/Localization Tray cleared by the FDA?
RNS Sterile, Disposable Breast Biopsy/Localization Tray (K955683) received a 510(k) decision of Substantially Equivalent on February 1, 1996, 49 days after the submission was received.
What is the product code of K955683?
The FDA product code is MJG – Device, Percutaneous, Biopsy, a Class I (low risk) device regulated under 21 CFR 878.4800.