STERIS CMAX XLT SURGICAL TABLE— 510(k) K090136
Substantially EquivalentSTERIS Corporation
FDA 510(k) clearance K090136 for STERIS CMAX XLT SURGICAL TABLE, Substantially Equivalent on 2009-03-20. Applicant: STERIS Corporation. Device class: 1.
Clearance details
- Applicant
- STERIS Corporation
- Product code
- Code FQO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4960
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mentor, OH, US
Recent devices under product code FQO
view allMore clearances from STERIS Corporation
view allAdverse events under product code FQO
product code FQO- Death
- 6
- Injury
- 145
- Malfunction
- 685
- Total
- 836
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 K090136
K-number listed on FDA's recall record- Z-0196-2015 — The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation.
- Z-2426-2012 — STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation. It accommodates all general surgical procedures including but not limited to, cardiac and vascular, endoscopic, gynecology, urology, nephrectomy, neurology, ophthalmologic, orthopedics and other procedures requiring intraoperative fluoroscopic C-arm imaging and also supports laparoscopic surgical technique for the largest surgical patients. The 5085SRT table is a variation of the 5085 table that enables patient transport on hard level surfaces within the surgical suite (from pre-operative areas to the operating room and again from the operating room to post operative recovery).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090136.
Data sourced from openFDA. This site is unofficial and independent of the FDA.