Class I General & Plastic Surgery device.
K854906 is an FDA 510(k) clearance for the PERCUTANEOUS NEPHROSTOMY SETS (OTTO). Classified as Catheter, Nephrostomy, General & Plastic Surgery (product code GBO), Class I - General Controls.
Submitted by Angiomed U.S., Inc. (Anaheim, US). The FDA issued a Cleared decision on January 24, 1986.
This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.
| 510(k) Number | K854906 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 1986 |
| Decision Date | January 24, 1986 |
| Days to Decision | - |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Third-party Review | No - reviewed directly by FDA |
| Product Code | GBO Catheter, Nephrostomy, General & Plastic Surgery |
| Device Class | Class 1 - General Controls |
| CFR Regulation | 21 CFR 878.4200 |
Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.
Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.