Submission Details
| 510(k) Number | K081640 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 11, 2008 |
| Decision Date | May 06, 2009 |
| Days to Decision | 329 days |
| Submission Type | Abbreviated |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Abbreviated
GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS
May 2009
Decision
329d
Days
Class 2
Risk
About This 510(k) Submission
K081640 is an FDA 510(k) clearance for the GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS, a Clip, Aneurysm (Class II — Special Controls, product code HCH), submitted by Gimmi GmbH (Saint Paul, US). The FDA issued a Cleared decision on May 6, 2009, 329 days after receiving the submission on June 11, 2008. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5200.
Device Classification
| Product Code | HCH — Clip, Aneurysm |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.5200 |
Manufacturer
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