Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector Cable
FDA 510(k) K081954 · Gyrus Acmi, Inc.
510(k) numberK081954
Submission
- Device name
- Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector Cable
- Applicant
- Gyrus Acmi, Inc.
Southborough, MA, US - Received
- July 9, 2008
- Decision date
- July 31, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector Cable cleared by the FDA?
Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector Cable (K081954) received a 510(k) decision of Substantially Equivalent on July 31, 2008, 22 days after the submission was received.
What is the product code of K081954?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.