NEZHAT-DORSEY (TM) ELECTROSHIELD(TM) PROBES AND ACCESSORIES— 510(k) K945317
Substantially EquivalentAmerican Hydro-Surgical Instruments, Inc.
FDA 510(k) clearance K945317 for NEZHAT-DORSEY (TM) ELECTROSHIELD(TM) PROBES AND ACCESSORIES, Substantially Equivalent on 1995-02-01. Applicant: American Hydro-Surgical Instruments, Inc.. Device class: 2.
Clearance details
- Applicant
- American Hydro-Surgical Instruments, 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
- Delray Beach, FL, US
Recent devices under product code GEI
view allMore clearances from American Hydro-Surgical Instruments, Inc.
view all- K953574 — NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER
- K953481 — NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAGSQUEEZER
- K952070 — NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANS
- K946380 — NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V)
- K951300 — NEZHAT-DORSEY THERMAL RETENTION SYSTEM
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.