Nexcore GI Insufflator— 510(k) K162332
Substantially EquivalentNexcore Technology, LLC
FDA 510(k) clearance K162332 for Nexcore GI Insufflator, Substantially Equivalent on 2016-09-29. Applicant: Nexcore Technology, LLC. Device class: 2.
Clearance details
- Applicant
- Nexcore Technology, LLC
- Product code
- Code FCX
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Winchester, MA, US
Recent devices under product code FCX
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