Contura Lumen Marker
FDA 510(k) K082264 · Senorx, Inc.
510(k) numberK082264
Submission
- Device name
- Contura Lumen Marker
- Applicant
- Senorx, Inc.
Aliso Viejo, CA, US - Received
- August 11, 2008
- Decision date
- September 12, 2008
- Decision
- Unknown (SESU)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| 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 |
| K081085 | Starchmark Biopsy Site Marker, Model STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GSNEU · Traditional | 08/01/2008SE |
| K081170 | Prostate Tissue MarkerNEU · Traditional | 05/28/2008SE |
| K081079 | Contura MLB Source Applicator for BrachytherapyJAQ · Traditional | 05/02/2008SESU |
| K080791 | Contura Multi-Lumen Balloon Source Applicator for Brachytherapy, Models B001-45 and…JAQ · Traditional | 04/30/2008SESU |
Questions and answers
When was Contura Lumen Marker cleared by the FDA?
Contura Lumen Marker (K082264) received a 510(k) decision of Unknown on September 12, 2008, 32 days after the submission was received.
What is the product code of K082264?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.