Sheathing Technologies Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 7
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1006-2026 | Class II | Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4 | November 17, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K153212 | Sheathes Ultrasound Probe Covers | March 4, 2016 |
| K130041 | SHEATHES STERILE ULTRASOUND GEL | February 6, 2013 |
| K112827 | SHEATHES ULTRASOND GEL | June 22, 2012 |
| K100966 | COLONOSCOPE/SIGMOIDOSCOPE SHEATHES | August 3, 2010 |
| K091828 | SHEATHESISO ULTRASOUND TRANSDUCER COVER | September 28, 2009 |
| K043425 | SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCE | February 28, 2005 |
| K990175 | SHEATHES (NON-LATEX), STERILE | April 21, 1999 |