MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305— 510(k) K911160
Substantially EquivalentMentor O & O, Inc.
FDA 510(k) clearance K911160 for MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305, Substantially Equivalent on 1991-05-02. Applicant: Mentor O & O, Inc.. Device class: 2.
Clearance details
- Applicant
- Mentor O & O, 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
- Norwell, MA, US
Recent devices under product code GEI
view allMore clearances from Mentor O & O, 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 K911160
K-number listed on FDA's recall record- Z-1594-2022 — Wetfield Eraser Bipolar Hemostatic Eraser Wet-Field Eraser 23 Gauge Tapered Model Number: 221265
- Z-1281-2022 — BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control bleeding by the use of high frequency electrical current Part Number: 221251
- Z-1539-2018 — WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedures.
- Z-1801-2018 — Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K911160.
Data sourced from openFDA. This site is unofficial and independent of the FDA.