Company ยท US
Sheathing Technologies, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2016. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
1recalls (1 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 4, 2016 | K153212 | Sheathes Ultrasound Probe Covers Sheathing Technologies, Inc. | ITX |
| Feb 6, 2013 | K130041 | SHEATHES STERILE ULTRASOUND GEL Sheathing Technologies, Inc. | MUI |
| Jun 22, 2012 | K112827 | SHEATHES ULTRASOND GEL Sheathing Technologies, Inc. | MUI |
| Aug 3, 2010 | K100966 | COLONOSCOPE/SIGMOIDOSCOPE SHEATHES Sheathing Technologies, Inc. | FDF |
| Sep 28, 2009 | K091828 | SHEATHESISO ULTRASOUND TRANSDUCER COVER Sheathing Technologies, Inc. | ITX |
| Feb 28, 2005 | K043425 | SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER) Sheathing Technologies, Inc. | ITX |
| Apr 21, 1999 | K990175 | SHEATHES (NON-LATEX), STERILE Sheathing Technologies, Inc. | ITX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 31, 2025 | Sheathing Technologies Inc Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long, Indivi Open, Classified |
ITX | K153212 |