Invasix Ltd. · 89-08 · ISRAEL
For Invasix Ltd. · 89-08 · ISRAEL, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is ISRAEL; product is Invasix BodyTite (aka Invasix RFAL; product code is 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories; date published is 04/19/2013; address is Tavor Building , Pob 533 , Yokneam, Ha Zafon ISRAEL, verified against its source on 2026-09-16.
- Firm
- Invasix Ltd. verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- ISRAEL verified
- Address
- Tavor Building , Pob 533 , Yokneam, Ha Zafon ISRAEL verified
- Date published
- 04/19/2013 verified
- Product code
- 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories verified
- Product
- Invasix BodyTite (aka Invasix RFAL verified
- FDA notes
- Class II verified
What the source says
Invasix Ltd. Date Published : 04/19/2013 Tavor Building , Pob 533 , Yokneam, Ha Zafon ISRAEL 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories Date Published: 04/19/2013 Desc: Invasix BodyTite (aka Invasix RFAL Notes: Class II
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.