INJECTION NEEDLE PROBE/DEVICE-TUNIS— 510(k) K983765
Substantially EquivalentXimed/Prosure/Injectx
FDA 510(k) clearance K983765 for INJECTION NEEDLE PROBE/DEVICE-TUNIS, Substantially Equivalent on 1998-12-11. Applicant: Ximed/Prosure/Injectx. Device class: 2.
Clearance details
- Applicant
- Ximed/Prosure/Injectx
- Product code
- Code FBK
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code FBK
view allMore clearances from Ximed/Prosure/Injectx
view all- K002269 — ELECTROSURGICAL PROBES AND DEVICES-GELTX
- K994151 — PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES
- K983200 — INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX
- K981256 — ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE
- K974484 — ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE
Adverse events under product code FBK
product code FBK- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.