FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Kii Structural Balloon Access System
K Number: K252442
·
Decision Oct 31, 2025
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
45
Review Days
88
Basic Information
- Device Name
- Kii Structural Balloon Access System
- K Number
- K252442
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Applied Medical Resources Corp.
- Date Received
- August 4, 2025
- Decision Date
- October 31, 2025
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Applied Medical Resources Corp.
| K Number | Device Name | ||
|---|---|---|---|
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| K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device | Oct 2, 2025 | Substantially Equivalent |
| K201212 | Voyant Open Fusion Device | Jun 5, 2020 | Substantially Equivalent |
| K200598 | Voyant Maryland Fusion Device | Apr 8, 2020 | Substantially Equivalent |
| K193292 | Voyant 5mm Fusion Device, Voyant Maryland Fusion Device | Dec 20, 2019 | Substantially Equivalent |
| K191294 | Transvaginal Access Platform | Sep 6, 2019 | Substantially Equivalent |
| K182653 | Voyant Maryland Fusion Device | Nov 14, 2018 | Substantially Equivalent |
| K182244 | Voyant Electrosurgical Generator | Oct 11, 2018 | Substantially Equivalent |
| K182024 | Dissecting Balloon System | Aug 30, 2018 | Substantially Equivalent |
| K171701 | GelPOINT Path Transanal Access Platform | Jul 20, 2017 | Substantially Equivalent |