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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 9 of 9 Results
510(K) Number: K060243
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Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1... 1 02/11/2025 FEI # 2429304
Olympus Corporation of the Americas
K-202 GUIDE SHEATH Kit 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells... 2 02/05/2021 FEI # 3003995201
Aomori Olympus Co., Ltd.
K-203 GUIDE SHEATH Kit 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells... 2 02/05/2021 FEI # 3003995201
Aomori Olympus Co., Ltd.
K-204 GUIDE SHEATH KIT 2.6MM, model no. K-204 - Product Usage: Used with endoscopes to collect cells... 2 02/05/2021 FEI # 3003995201
Aomori Olympus Co., Ltd.
K-201 GUIDE SHEATH KIT 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells... 2 02/05/2021 FEI # 3003995201
Aomori Olympus Co., Ltd.
K-202 GUIDE SHEATH KIT 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells... 2 02/05/2021 FEI # 3003995201
Aomori Olympus Co., Ltd.
K-203 GUIDE SHEATH KIT 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells... 2 02/05/2021 FEI # 3003995201
Aomori Olympus Co., Ltd.
K-201 GUIDE SHEATH Kit 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells... 2 02/05/2021 FEI # 3003995201
Aomori Olympus Co., Ltd.
K-204 GUIDE SHEATH Kit 2.6MM, model no K-204 - Product Usage: Used with endoscopes to collect cells ... 2 02/05/2021 FEI # 3003995201
Aomori Olympus Co., Ltd.
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