search_device510k

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Search FDA 510(k) premarket notification clearances from the scite device database. Use this tool to find medical device clearances by device name, product code, applicant, clearance type, or K number. Returns clearances with device details, decision info, applicant information, and regulatory classifications. 510(k) is the FDA's premarket notification process -- manufacturers must demonstrate that their device is substantially equivalent to a legally marketed device before it can be sold. **Parameters:** - q: Search query string (device name, product code, applicant, K number, etc.) - f: Space-delimited filters in `field:"value"` format (e.g. `device.deviceClass:"2" decision.decisionCode:"SESE"`) - p: Page number (default: 1) - s: Sort field (default: _relevance). Options: - _relevance: relevance score (sortDir ignored) - device.device_class: device risk classification - device.date_received: date FDA received the submission - decision.decision_date: date of FDA decision - sortDir: Sort direction, asc or desc (default: desc). Ignored when s is _relevance. **Returns:** Device 510(k) clearances with kNumber, title, summaryText, device info (name, class, productCode, clearanceType, regulationNumber), decision info (code, description, date, committee), applicant details, and tags. **Note:** This tool returns structured clearance metadata only. For the actual narrative content of 510(k) summary documents (test results, substantial equivalence reasoning, indications for use, performance data), use `search_510k_summaries` instead.