# Sheathing Technologies, Inc.

- Location (FDA's records): Morgan Hill, CA
- FDA decisions: 7 (1999–2016): 7 510(k) clearances
- Product codes: ITX (4), MUI (2), FDF (1)
- Predicates its devices cite: 12 (2 its own); citations of its devices by later devices: 7 (2 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- CIVCO Medical Instruments Co., Inc.: 3 (https://510kreport.com/company/civco-medical-instruments)
- Sonomed Technology, Inc.: 2 (https://510kreport.com/company/sonomed-technology)
- Dymax Corp: 1 (https://510kreport.com/company/dymax)
- Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa: 1 (https://510kreport.com/company/turkuaz-saglik-hizmetleri-medikal-temizlik-kimyasa)
- Sonotech, Inc.: 1 (https://510kreport.com/company/sonotech)
- Stryker GI: 1 (https://510kreport.com/company/stryker-gi)
- Sightline Technologies, Ltd.: 1 (https://510kreport.com/company/sightline-technologies)

## Firms that cite its devices most
- H R Pharmaceuticals, Inc.: 2 (https://510kreport.com/company/h-r-pharmaceuticals)
- B-K Medical Aps: 1 (https://510kreport.com/company/b-k-medical)
- Gi Scientific, LLC: 1 (https://510kreport.com/company/gi-scientific)
- Bluemtech: 1 (https://510kreport.com/company/bluemtech)

## Its most-cited devices
- K112827: Sheathes Ultrasond Gel (2012), cited by 3
- K043425: Sheathes Needle Guide, Model NG-SR-a-484-Kit (There Will BE Various Model Numbers Based on Transducer and Cover) (2005), cited by 1
- K130041: Sheathes Sterile Ultrasound Gel (2013), cited by 1
- K100966: Colonoscope/Sigmoidoscope Sheathes (2010), cited by 1
- K990175: Sheathes (Non-Latex), Sterile (1999), cited by 1

## Recent decisions
- K153212: Sheathes Ultrasound Probe Covers (Mar 4, 2016)
- K130041: Sheathes Sterile Ultrasound Gel (Feb 6, 2013)
- K112827: Sheathes Ultrasond Gel (Jun 22, 2012)
- K100966: Colonoscope/Sigmoidoscope Sheathes (Aug 3, 2010)
- K091828: Sheathesiso Ultrasound Transducer Cover (Sep 28, 2009)
- K043425: Sheathes Needle Guide, Model NG-SR-a-484-Kit (There Will BE Various Model Numbers Based on Transducer and Cover) (Feb 28, 2005)
- K990175: Sheathes (Non-Latex), Sterile (Apr 21, 1999)

Source page: https://510kreport.com/company/sheathing-technologies