K132581 is an FDA 510(k) clearance for the MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE S.... Classified as Staple, Implantable (product code GDW), Class II - Special Controls.
Submitted by Cardica, Inc. (Redwood City, US). The FDA issued a Cleared decision on January 7, 2014 after a review of 144 days - within the typical 510(k) review window.
This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.
NCT01476761
Completed
Interventional
Industry-sponsored
MicroCutter in Surgical Stapling - European Trial I
The Cardica MicroCutter in Surgical Stapling: A Prospective, Open-label, Multi-center Study
| Condition studied |
Thoracic |
| Study design |
Single group |
| Eligibility |
All sexes
|
| Principal investigator |
Andreas Kithe, M.D. |
| Sponsor |
Cardica, Inc
(industry)
|
Started 2011-11-01
→
Primary completion 2013-06-01
→
Completed 2013-07-01
Primary outcome
Composite adverse event rate
Study completed - no results published.
This trial concluded in 2013 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov