Habib EUS RFA— 510(k) K161305
Substantially EquivalentEmcision , Ltd.
FDA 510(k) clearance K161305 for Habib EUS RFA, Substantially Equivalent on 2016-07-07. Applicant: Emcision , Ltd.. Device class: 2.
Clearance details
- Applicant
- Emcision , Ltd.
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- London, GB
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More clearances from Emcision , Ltd.
view allAdverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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 →
Recalls naming K161305
K-number listed on FDA's recall record- Z-0667-2020 — Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.
- Z-0668-2020 — Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161305.
Data sourced from openFDA. This site is unofficial and independent of the FDA.