Gimmi Aneurysm Clips and Applying Forceps
FDA 510(k) K081640 · Gimmi GmbH
510(k) numberK081640
Submission
- Device name
- Gimmi Aneurysm Clips and Applying Forceps
- Applicant
- Gimmi GmbH
Saint Paul, MN, US - Received
- June 11, 2008
- Decision date
- May 6, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Gimmi Aneurysm Clips and Applying Forceps cleared by the FDA?
Gimmi Aneurysm Clips and Applying Forceps (K081640) received a 510(k) decision of Substantially Equivalent on May 6, 2009, 329 days after the submission was received.
What is the product code of K081640?
The FDA product code is HCH – Clip, Aneurysm, a Class II (moderate risk) device regulated under 21 CFR 882.5200.