MEDICON INSTRUMENTS UNIPOLAR COAGULATION ELECTRODES— 510(k) K936249
Substantially EquivalentMedicon Instruments, Inc.
FDA 510(k) clearance K936249 for MEDICON INSTRUMENTS UNIPOLAR COAGULATION ELECTRODES, Substantially Equivalent on 1994-07-21. Applicant: Medicon Instruments, Inc.. Device class: 2.
Clearance details
- Applicant
- Medicon 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
- Washington, DC, US
Recent devices under product code GEI
view allMore clearances from Medicon Instruments, Inc.
view all- K936246 — MEDICON INSTRUMENTS BIPOLAR FORCEPTS AND ELECTRODES
- K936262 — DISSECTORS, FORCEPS, SCISSORS, DILATION SETS, AND GALL STONE COLLECTORS
- K936247 — MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES
- K936248 — MEDICON INSTRUMENTS CHOLANGIOGRAPHY NEEDLES, GUIDE TUBES, INJECTION NEEDLES, VERRES INSUFFLATION NEEDLES AND HOLDERS
- K936250 — RETRACTORS, SPECULUM, CLIP APPLIER FOR TITANIUM CLIPS, 2-WAY STOP COCK, PALPATION PROBE, KNOT GUIDE, ROEDER LOOP
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.