Emf Pal II Main Generator and Irrigation Units and Accessories
FDA 510(k) K062171 · Ortho Development Corp.
510(k) numberK062171
Submission
- Device name
- Emf Pal II Main Generator and Irrigation Units and Accessories
- Applicant
- Ortho Development Corp.
Draper, UT, US - Received
- July 31, 2006
- Decision date
- May 25, 2007
- 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 Emf Pal II Main Generator and Irrigation Units and Accessories cleared by the FDA?
Emf Pal II Main Generator and Irrigation Units and Accessories (K062171) received a 510(k) decision of Substantially Equivalent on May 25, 2007, 298 days after the submission was received.
What is the product code of K062171?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.