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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K950166
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Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product De... 2 02/05/2026 Olympus Corporation of the Americas
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product De... 2 02/05/2026 Olympus Corporation of the Americas
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product De... 2 02/05/2026 Olympus Corporation of the Americas
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Desc... 2 02/05/2026 Olympus Corporation of the Americas
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Desc... 2 02/05/2026 Olympus Corporation of the Americas
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Desc... 2 02/05/2026 Olympus Corporation of the Americas
Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphinctero... 2 02/05/2026 Olympus Corporation of the Americas
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 Product De... 2 02/05/2026 Olympus Corporation of the Americas
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Desc... 2 02/05/2026 Olympus Corporation of the Americas
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Desc... 2 02/05/2026 Olympus Corporation of the Americas
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