CAUTERY TIP CLEANER, MODEL 30500— 510(k) K053433
Substantially EquivalentXodus Medical, Inc.
FDA 510(k) clearance K053433 for CAUTERY TIP CLEANER, MODEL 30500, Substantially Equivalent on 2006-01-19. Applicant: Xodus Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Xodus Medical, Inc.
- Product code
- 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
- New Kensington, PA, US
Recent devices under product code GEI
view allMore clearances from Xodus Medical, Inc.
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 K053433
K-number listed on FDA's recall record- Z-0149-2020 — Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical accessory
- Z-0150-2020 — Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgical accessory
- Z-0151-2020 — Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K053433.
Data sourced from openFDA. This site is unofficial and independent of the FDA.