FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45
K Number: K080791
·
Decision Apr 30, 2008
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
206
Applicant Total
30
Review Days
41
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Basic Information
- Device Name
- CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45
- K Number
- K080791
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5700
- Medical Specialty
- Radiology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Senorx, Inc.
- Date Received
- March 20, 2008
- Decision Date
- April 30, 2008
- Product Code
- JAQ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | FDA class 2 | Radiology |
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Other Clearances by Senorx, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K233220 | EnCor EnspireBreast Biopsy System (E4115, E4230); EnCor Breast Biopsy Driver (DRENCOR); EnCor MRI Breast Biopsy Driver (DRENCORMR); EnCor Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT) | Oct 27, 2023 | Substantially Equivalent |
| K210654 | EnCor Breast Biopsy Probe with Rinse Tube | Mar 31, 2021 | Substantially Equivalent |
| K161805 | EnCor MRI Introducer Set, EnCor Probe Introducer | Jul 19, 2016 | Substantially Equivalent |
| K131654 | STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER | Jun 27, 2013 | Substantially Equivalent |
| K093512 | ENCOR BREAST BIOPSY SYSTEM | Nov 20, 2009 | Substantially Equivalent |
| K092323 | CONTURA CAVITY MAINTENANCE CATHETER | Aug 19, 2009 | Substantially Equivalent |
| K082264 | CONTURA LUMEN MARKER | Sep 12, 2008 | Unknown |
| K081085 | STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS | Aug 1, 2008 | Substantially Equivalent |
| K081170 | PROSTATE TISSUE MARKER | May 28, 2008 | Substantially Equivalent |
| K081079 | CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY | May 2, 2008 | Unknown |