IRRIGATION SYSTEM— 510(k) K103239
Substantially EquivalentUnited States Endoscopy Group, Inc.
FDA 510(k) clearance K103239 for IRRIGATION SYSTEM, Substantially Equivalent on 2010-12-30. Applicant: United States Endoscopy Group, Inc.. Device class: 2.
Clearance details
- Applicant
- United States Endoscopy Group, Inc.
- Product code
- Code OCX
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mentor, OH, US
Recent devices under product code OCX
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view allRecalls naming K103239
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 K103239.
Data sourced from openFDA. This site is unofficial and independent of the FDA.