ClearanceBrief
510(k) K060243 ยท EOQ Bronchoscope (Flexible Or Rigid)

OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13

ApplicantOlympus Medical Systems Corporation, Melville NY, US
DecisionSubstantially Equivalent, Jun 23, 2006
ReceivedJan 31, 2006
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K060243

DateFirm and productCodeLinked 510(k)
Feb 11, 2025Olympus Corporation of the Americas
Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; M
Open, Classified		 EOQNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
K-201 GUIDE SHEATH Kit 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Terminated		 EOQNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
K-202 GUIDE SHEATH Kit 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Terminated		 EOQNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
K-203 GUIDE SHEATH Kit 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Terminated		 EOQNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
K-204 GUIDE SHEATH Kit 2.6MM, model no K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Terminated		 EOQNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
K-201 GUIDE SHEATH KIT 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Terminated		 EOQNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
K-202 GUIDE SHEATH KIT 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Terminated		 EOQNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
K-203 GUIDE SHEATH KIT 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Terminated		 EOQNone listed
Jan 4, 2021Aomori Olympus Co., Ltd.
K-204 GUIDE SHEATH KIT 2.6MM, model no. K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Terminated		 EOQNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.