Contura MLB Source Applicator for Brachytherapy
FDA 510(k) K081079 · Senorx, Inc.
510(k) numberK081079
Submission
- Device name
- Contura MLB Source Applicator for Brachytherapy
- Applicant
- Senorx, Inc.
Aliso Viejo, CA, US - Received
- April 16, 2008
- Decision date
- May 2, 2008
- Decision
- Unknown (SESU)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| K242961 | Intraluminal Applicator SetJAQ · Traditional | Varian Medical Systems | 11/26/2024SE |
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More from Braxx Biotech Co., Ltd.
| 510(k) | Device | Decision |
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| K233220 | EnCor EnspireBreast Biopsy System (E4115, E4230); EnCor Breast Biopsy Driver…KNW · Special | 10/27/2023SE |
| K210654 | EnCor Breast Biopsy Probe with Rinse TubeKNW · Special | 03/31/2021SE |
| K161805 | EnCor MRI Introducer Set, EnCor Probe IntroducerKNW · Special | 07/19/2016SE |
| K131654 | Starchmark Breast Tissue Marker; Starchmark Ultracor Breast Tissue MarkerNEU · Special | 06/27/2013SE |
| K093512 | Encor Breast Biopsy SystemKNW · Traditional | 11/20/2009SE |
| K092323 | Contura Cavity Maintenance CatheterJAQ · Traditional | 08/19/2009SE |
| K082264 | Contura Lumen MarkerJAQ · Traditional | 09/12/2008SESU |
| K081085 | Starchmark Biopsy Site Marker, Model STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GSNEU · Traditional | 08/01/2008SE |
| K081170 | Prostate Tissue MarkerNEU · Traditional | 05/28/2008SE |
| K080791 | Contura Multi-Lumen Balloon Source Applicator for Brachytherapy, Models B001-45 and…JAQ · Traditional | 04/30/2008SESU |
Questions and answers
When was Contura MLB Source Applicator for Brachytherapy cleared by the FDA?
Contura MLB Source Applicator for Brachytherapy (K081079) received a 510(k) decision of Unknown on May 2, 2008, 16 days after the submission was received.
What is the product code of K081079?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.