CPC by Soring GmbH
FDA 510(k) K030028 · Soring GmbH Medizintechnik
510(k) numberK030028
Submission
- Device name
- CPC by Soring GmbH
- Applicant
- Soring GmbH Medizintechnik
Denton, TX, US - Received
- January 3, 2003
- Decision date
- January 17, 2003
- 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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|---|---|---|
| K093511 | Soring MBC200/BCC140GEI · Traditional | 04/16/2010SE |
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| K012753 | Soring GmbH Sonoca 180/190LFL · Traditional | 11/13/2001SE |
| K993265 | Soring GmbH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600GEI · Special | 10/22/1999SE |
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Questions and answers
When was CPC by Soring GmbH cleared by the FDA?
CPC by Soring GmbH (K030028) received a 510(k) decision of Substantially Equivalent on January 17, 2003, 14 days after the submission was received.
What is the product code of K030028?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.