SuRgical Planner (SRP) BrainStorm— 510(k) K201465
Substantially EquivalentSurgical Theater, Inc.
FDA 510(k) clearance K201465 for SuRgical Planner (SRP) BrainStorm, Substantially Equivalent on 2020-07-17. Applicant: Surgical Theater, Inc.. Device class: 2.
Clearance details
- Applicant
- Surgical Theater, Inc.
- 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
Recent devices under product code LLZ
view allMore clearances from Surgical Theater, Inc.
view allAdverse 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 K201465
K-number listed on FDA's recall record- Z-0325-2026 — Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201465.
Data sourced from openFDA. This site is unofficial and independent of the FDA.