Savi Preparation Device
510(k) K101411
Savi Preparation Device is a medical device (FDA Class II; FDA product code JAQ, System, Applicator, Radionuclide, Remote-Controlled) made by Cianna Medical, Inc., cleared under FDA 510(k) K101411 on 12 Jul 2010, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK101411 | Date12 Jul 2010 | StatusActive |
Official records
- FDA 510(k) database K101411
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JAQ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5700
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code JAQ (System, Applicator, Radionuclide, Remote-Controlled).
- CT/MR M.A.C. Interstitial GYN Template, 15.5GElekta 1505-15.5 by Mick Radio-Nuclear Instruments, Inc.
- Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 30 degree, 70mm GM11013280 by Varian Medical Systems Deutschland GmbH
- REMOTE CONTROL RADIOISOTOPE APPLICATOR by Inter-Pal GmbH
- Clamping screw with fixation nut for bougies GM11007490 by Varian Medical Systems Deutschland GmbH
- PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189, 065, 189, 066, 189, 067 by Nucletron Corp.
- MICROSELECTRON PDR by Nucletron Corp.
- Titanium Flexible Geometry FSD Applicator Set (GM11013400) by Varian Medical Systems, Inc.
- CT/MR Vienna Ring & Tandem Acc Kit, Mick© 2.0mm 0720-2.0 by Mick Radio-Nuclear Instruments, Inc.
- MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM by Isotopes and Metals, Ltd.
- BIOLUCENT APPLICATOR, MODEL RTA-XX by Biolucent, Inc.