Electrosurgical Infant Patient Return Electrode, Dual Plate with Cord, Model Ep 211M
FDA 510(k) K071080 · E Surgical, LLC
510(k) numberK071080
Submission
- Device name
- Electrosurgical Infant Patient Return Electrode, Dual Plate with Cord, Model Ep 211M
- Applicant
- E Surgical, LLC
Walnut Creek, CA, US - Received
- April 17, 2007
- Decision date
- August 31, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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Questions and answers
When was Electrosurgical Infant Patient Return Electrode, Dual Plate with Cord, Model Ep 211M cleared by the FDA?
Electrosurgical Infant Patient Return Electrode, Dual Plate with Cord, Model Ep 211M (K071080) received a 510(k) decision of Substantially Equivalent on August 31, 2007, 136 days after the submission was received.
What is the product code of K071080?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.