Seednet System and Seednetgold System
FDA 510(k) K031117 · Galil Medical , Ltd.
510(k) numberK031117
Submission
- Device name
- Seednet System and Seednetgold System
- Applicant
- Galil Medical , Ltd.
Yokneam, IL - Received
- April 8, 2003
- Decision date
- May 23, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEH – Unit, Cryosurgical, Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4350
- Specialty
- General, Plastic Surgery
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| K162599 | IcePearl 2.1 CX L, IceForce 2.1 CX LGEH · Special | 10/11/2016SE |
| K152133 | IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit…GEH · Special | 08/28/2015SE |
| K143564 | Visual-ICE Cryoablation System, Software Revision 1.3.1GEH · Special | 03/05/2015SE |
| K141485 | Icesphere 1.5 90 Cryoblation Needle, Iceshpere 1.5 Cyoblation NeedleGEH · Special | 07/02/2014SE |
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Questions and answers
When was Seednet System and Seednetgold System cleared by the FDA?
Seednet System and Seednetgold System (K031117) received a 510(k) decision of Substantially Equivalent on May 23, 2003, 45 days after the submission was received.
What is the product code of K031117?
The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.