510(k) K252442
- Device
- Kii Structural Balloon Access System
- Applicant
- Applied Medical Resources Corp.
- 510(k) number
- K252442
- Product code
- GCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-10-31
- Date received
- 2025-08-04
- Regulation
- 876.1500
- Classification name
- Laparoscope, General & Plastic Surgery
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Derek Greene
- Address
- 22872 Avenida Empresa Rancho Santa CA US 92688 92688
FDA Registration Numbers
- 3002808148
- 1450662
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Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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