NEZHAT-DORSEY REUSABLE UNIPOLAR COAGULATOR PROBE INSERTS— 510(k) K952421
Substantially EquivalentAmerican Hydro-Surgical Instruments, Inc.
FDA 510(k) clearance K952421 for NEZHAT-DORSEY REUSABLE UNIPOLAR COAGULATOR PROBE INSERTS, Substantially Equivalent on 1995-06-08. Applicant: American Hydro-Surgical Instruments, Inc.. Device class: 2.
Clearance details
- Applicant
- American Hydro-Surgical Instruments, Inc.
- Product code
- Product code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Delray Beach, FL, US
Recent devices under product code GCJ
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- 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 GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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.