Data / Medical devices / United States / Sheathing Technologies, Inc.
Sheathing Technologies, Inc.: FDA-registered device maker in Morgan Hill, CA, United States, 9 510(k) clearances
Sheathing Technologies, Inc. is registered with the FDA (registration 2950776) in Morgan Hill, CA, United States. It lists 6 device types. The FDA files 9 510(k) clearances under its listings, the newest dated March 4, 2016. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2950776
- FEI number
- 1000135740
- Address
- 675 Jarvis DR., Morgan Hill, CA, United States, 95037
- Owner or operator
- SHEATHING TECHNOLOGIES, INC. (9006763)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- December 11, 2007
- Registered through
- 2026
- Brand names listed
- Sheathes, Sheathes Needle Guide System, Sheathes Sterile Ultrasound Gel, Sheathes Ultrasound Gel, Sheathes Ultrasound Probe Covers, Sheathes3D, SheathesISO
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biopsy Needle Guide Kit | OIJ | 2 | Manufacturer | accessdata.fda.gov |
| Colonoscope And Accessories, Flexible/Rigid | FDF | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Endoscopic Contamination Prevention Sheath | ODB | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Media, Coupling, Ultrasound | MUI | 2 | Manufacturer | accessdata.fda.gov |
| Radiology-Diagnostic Kit | OIP | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 4, 2016 | K153212 | Sheathes Ultrasound Probe Covers | ITX | Substantially Equivalent | Sheathing Technologies, Inc. | accessdata.fda.gov |
| February 6, 2013 | K130041 | SHEATHES STERILE ULTRASOUND GEL | MUI | Substantially Equivalent | Sheathing Technologies, Inc. | accessdata.fda.gov |
| June 22, 2012 | K112827 | SHEATHES ULTRASOND GEL | MUI | Substantially Equivalent | Sheathing Technologies, Inc. | accessdata.fda.gov |
| August 3, 2010 | K100966 | COLONOSCOPE/SIGMOIDOSCOPE SHEATHES | FDF | Substantially Equivalent | Sheathing Technologies, Inc. | accessdata.fda.gov |
| September 28, 2009 | K091828 | SHEATHESISO ULTRASOUND TRANSDUCER COVER | ITX | Substantially Equivalent | Sheathing Technologies, Inc. | accessdata.fda.gov |
| February 28, 2005 | K043425 | SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER) | ITX | Substantially Equivalent | Sheathing Technologies, Inc. | accessdata.fda.gov |
| April 21, 1999 | K990175 | SHEATHES (NON-LATEX), STERILE | ITX | Substantially Equivalent | Sheathing Technologies, Inc. | accessdata.fda.gov |
| February 10, 1997 | K963831 | SHEATHES (NON-LATEX) | ITX | Substantially Equivalent | Medical Resources | accessdata.fda.gov |
| January 6, 1994 | K925869 | SHEATHES, STERILE SHEATHES | ITX | Substantially Equivalent | Mayer Laboratories | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 17, 2025 | 98068 | Class II | Ongoing | 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, Individually Wrapped, Box | Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk. | accessdata.fda.gov |
Compare with other makers
- All makers of Media, Coupling, Ultrasound
- All makers of Biopsy Needle Guide Kit
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Radiology-Diagnostic Kit
- All makers of Colonoscope And Accessories, Flexible/Rigid
- All makers of Endoscopic Contamination Prevention Sheath
Updated December 31, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.