Echo-Coat Ultrasound Needles
FDA 510(k) K983647 · Sts Biopolymers
510(k) numberK983647
Submission
- Device name
- Echo-Coat Ultrasound Needles
- Applicant
- Sts Biopolymers
Rockville, MD, US - Received
- October 16, 1998
- Decision date
- January 20, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K955683 | RNS Sterile, Disposable Breast Biopsy/Localization TrayMJG · Traditional | Contour Fabricators of Florida, Inc. | 02/01/1996SE |
| 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 |
Questions and answers
When was Echo-Coat Ultrasound Needles cleared by the FDA?
Echo-Coat Ultrasound Needles (K983647) received a 510(k) decision of Substantially Equivalent on January 20, 1999, 96 days after the submission was received.
What is the product code of K983647?
The FDA product code is MJG – Device, Percutaneous, Biopsy, a Class I (low risk) device regulated under 21 CFR 878.4800.