Endoscopic Contamination Prevention Sheath
Gastroenterology, Urology · 21 CFR 876.1500
To protect an endoscope from contamination by providing a barrier between the body and the endoscope.
Recent MDR events
48 adverse event reports on file
- CYSTOSCOPE SHEATH, 22 FR.Jul 10, 2026InjuryKarl Storz Se & Co. Kg2020550-2026-01595
- CYSTOSCOPE SHEATH, 22 FR.Jul 10, 2026InjuryKarl Storz Se & Co. Kg9610617-2026-01595
- CYSTOSCOPE SHEATH, 17 FR.May 15, 2026InjuryKarl Storz Se & Co. Kg2020550-2026-01097
- CYSTOSCOPE SHEATH, 17 FR.May 15, 2026InjuryKarl Storz Se & Co. Kg9610617-2026-01097
- CYSTOSCOPE SHEATH, 22 FR.May 14, 2026InjuryKarl Storz Se & Co. Kg2020550-2026-01102
- CYSTOSCOPE SHEATH, 22 FR.May 14, 2026InjuryKarl Storz Se & Co. Kg9610617-2026-01102
- CYSTOSCOPE SHEATH, 22 FR.May 13, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-01092
- CYSTOSCOPE SHEATH, 22 FR.May 13, 2026InjuryKarl Storz Se & Co. Kg2020550-2026-01092
- SACHSE URETHROTOME SHEATH, 21 FR.May 12, 2026InjuryKarl Storz Se & Co. Kg2020550-2026-01081
- CATHETER DEFLECTING MECHANISMMar 13, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-00559
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
11 firms currently registered for this product code
Sterigenics Us Llc
Los Angeles, CA, US
Usgi Medical
SAN CLEMENTE, CA, US
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Karl Storz Se & Co Kg
TUTTLINGEN Baden-Wurttemberg, DE
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Insightra Medical, Inc.
Clarksville, TN, US
Sheathing Technologies, Inc.
MORGAN HILL, CA, US
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Karl Storz Endoscopy-america, Inc.
Auburn, MA, US
Karl Storz Se & Co. Kg
NEUHAUSEN OBECK Baden-Wurttemberg, DE
Sterigenics U.s., Llc
Corona, CA, US
510(k) clearances
5 clearances for this product code
- Gi Scientific, LLCOct 8, 2019
K183171 · ScopeSeal Duodenoscope Protective Device
- Lumenr, LLCApr 19, 2016
K153698 · LumenR Tissue Retractor System
- Minos MedicalJun 10, 2008
K080550 · MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22
- Olympus Medical Systems CorporationMar 17, 2006
K060475 · EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8
- Karl Storz Endoskop GmbHSep 14, 1994
K943697 · TROCARS,CANNULAE,SHEATHS,OBTURATORS