DeviceClearance

SuRgical Planner (SRP)— 510(k) K170793

Substantially Equivalent

Surgical Theater, LLC

FDA 510(k) clearance K170793 for SuRgical Planner (SRP), Substantially Equivalent on 2018-02-12. Applicant: Surgical Theater, LLC. Device class: 2.

Clearance details

Applicant
Surgical Theater, LLC
Product code
Code LLZ
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mayfield Village, OH, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LLZ

product code LLZ
Death
13
Total
13

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K170793

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170793.

Data sourced from openFDA. This site is unofficial and independent of the FDA.