GelPOINT Path Transanal Access Platform— 510(k) K171701
Substantially EquivalentApplied Medical Resources Corp.
FDA 510(k) clearance K171701 for GelPOINT Path Transanal Access Platform, Substantially Equivalent on 2017-07-20. Applicant: Applied Medical Resources Corp.. Device class: 2.
Clearance details
- Applicant
- Applied Medical Resources Corp.
- Product code
- Code FER
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rancho Santa, CA, US
Recent devices under product code FER
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view allRecalls naming K171701
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171701.
Data sourced from openFDA. This site is unofficial and independent of the FDA.