ARVIS Surgical Navigation System— 510(k) K203115
Substantially EquivalentInsight Medical Systems, Inc.
FDA 510(k) clearance K203115 for ARVIS Surgical Navigation System, Substantially Equivalent on 2021-07-14. Applicant: Insight Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Insight Medical Systems, Inc.
- Product code
- Code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Laguna Hills, CA, US
Recent devices under product code OLO
view allMore clearances from Insight Medical Systems, Inc.
view allAdverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
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 K203115
K-number listed on FDA's recall record- Z-2292-2026 — Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C; IN-28050, Tracker E
- Z-2293-2026 — Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K203115.
Data sourced from openFDA. This site is unofficial and independent of the FDA.