Align® Cover and Pad Guidance Tool— 510(k) K260114
Substantially EquivalentCIVCO Medical Instruments Co., Inc.
FDA 510(k) clearance K260114 for Align® Cover and Pad Guidance Tool, Substantially Equivalent on 2026-09-24. Applicant: CIVCO Medical Instruments Co., Inc.. Device class: 2.
Summary
The Align Cover and Pad Guidance Tool from CIVCO Medical Instruments Co., Inc. is filed under ITX, diagnostic ultrasonic transducers. The name points to an accessory (a cover, a pad, and a guidance tool) rather than a transducer itself, but the record doesn't describe how the pieces are used.
Class II, 21 CFR 892.1570. The Radiology panel reviewed it as a Traditional 510(k).
CIVCO filed from Coralville, Iowa. Review took 253 days (January 14 to September 24, 2026).
Clearance details
- Applicant
- CIVCO Medical Instruments Co., Inc.
- Product code
- Product code ITX
- Device class
- Class 2
- Regulation
- 21 CFR 892.1570
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Coralville, IA, US
Recent devices under product code ITX
view allMore clearances from CIVCO Medical Instruments Co., Inc.
view allAdverse events under product code ITX
product code ITX- Death
- 6
- Injury
- 137
- Malfunction
- 2,036
- Total
- 2,179
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.