DAVOL ELECTRO MEDICAL SYSTEMS— 510(k) K810273
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K810273 for DAVOL ELECTRO MEDICAL SYSTEMS, Substantially Equivalent on 1981-03-04. Applicant: C.R. Bard, Inc.. Device class: 2.
Clearance details
- Applicant
- C.R. Bard, 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
- Warrendale, PA, US
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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, 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 K810273
K-number listed on FDA's recall record- Z-0725-2013 — TUR/Endoscopic Cable, 10 feet (3.05 mm), REF/Catalog No. 135171, Disposable, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
- Z-0727-2013 — ELECTROSURGICAL ENT NEEDLE ELECTRODE, 6 inch with Extended Insulation, REF/Catalog No. 138025, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K810273.
Data sourced from openFDA. This site is unofficial and independent of the FDA.