gi-4000 Electrosurgical Generator
FDA 510(k) K192265 · United States Endoscopy Group, Inc.
510(k) numberK192265
Submission
- Device name
- gi-4000 Electrosurgical Generator
- Applicant
- United States Endoscopy Group, Inc.
Mentor, OH, US - Received
- August 21, 2019
- Decision date
- May 21, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 gi-4000 Electrosurgical Generator cleared by the FDA?
gi-4000 Electrosurgical Generator (K192265) received a 510(k) decision of Substantially Equivalent on May 21, 2020, 274 days after the submission was received.
What is the product code of K192265?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.