Prostec 125I Branchytherapy Snapseed
FDA 510(k) K001366 · Prostec, LLC
510(k) numberK001366
Submission
- Device name
- Prostec 125I Branchytherapy Snapseed
- Applicant
- Prostec, LLC
Miami, FL, US - Received
- March 31, 2000
- Decision date
- September 19, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Isoray Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K993280 | Prostec 125I Brachytherapy SeedsKXK · Traditional | 03/14/2000SE |
Questions and answers
When was Prostec 125I Branchytherapy Snapseed cleared by the FDA?
Prostec 125I Branchytherapy Snapseed (K001366) received a 510(k) decision of Substantially Equivalent on September 19, 2000, 172 days after the submission was received.
What is the product code of K001366?
The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.