CONMED STEALTH NON-STICK ACCESSORY ELECTRODE, MODEL 138XXX— 510(k) K991855

Substantially Equivalent

Conmedcorp

FDA 510(k) clearance K991855 for CONMED STEALTH NON-STICK ACCESSORY ELECTRODE, MODEL 138XXX, Substantially Equivalent on 1999-06-15. Applicant: Conmedcorp. Device class: 2.

Clearance details

Applicant: Conmedcorp
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 1999-06-01
Decision date: 1999-06-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Utica, NY, US

Download summary PDF View on FDA.gov ↗

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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, 2020-01-01 through 2026-04-23. 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 K991855

K-number listed on FDA's recall record

Z-0720-2013 — Goldvac(TM) UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7521-001, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.Class II·Terminated·ConMed Corporation·20121227
Z-0721-2013 — Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7523-001, Sterile, Rx ONLY -- CONMED CORPORATION, Electrosurgical, Cutting and Coagulation and Accessories.Class II·Terminated·ConMed Corporation·20121227
Z-0722-2013 — Goldvac(TM) UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 60-7524-001, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.Class II·Terminated·ConMed Corporation·20121227
Z-0723-2013 — Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 60-7526-001, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.Class II·Terminated·ConMed Corporation·20121227
Z-0729-2013 — UltraClean(R) Accessory Electrode, 1 inch Coated Blade, REF/Catalog No. 139100, Single Use, Sterile, Rx ONLY --CONMED CORPORATION, Electrosurgical, Cutting and Coagulation and Accessories.Class II·Terminated·ConMed Corporation·20121227
Z-0730-2013 — UltraClean(R) Accessory Electrode 1 inch Coated Needle, REF/Catalog No. 139102, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.Class II·Terminated·ConMed Corporation·20121227
Z-0731-2013 — UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 139104EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 Electrosurgical, Cutting and Coagulation and Accessories.Class II·Terminated·ConMed Corporation·20121227
Z-0732-2013 — UltraClean(R) Accessory Electrode 1 inch Coated Needle with Extended Insulation, REF/Catalog No. 139105EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.Class II·Terminated·ConMed Corporation·20121227
Z-0733-2013 — UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 139107, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION, Electrosurgical, Cutting and Coagulation and Accessories.Class II·Terminated·ConMed Corporation·20121227
Z-0734-2013 — UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulation, REF/Catalog No. 139108, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.Class II·Terminated·ConMed Corporation·20121227
Z-0735-2013 — UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 139110EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.Class II·Terminated·ConMed Corporation·20121227
Z-0736-2013 — UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 139112, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.Class II·Terminated·ConMed Corporation·20121227
Z-0737-2013 — UltraClean(R) Accessory Electrode 4 inch Coated Blade with Extended Insulation, REF/Catalog No. 139112EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.Class II·Terminated·ConMed Corporation·20121227

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K991855.

Data sourced from openFDA. This site is unofficial and independent of the FDA.