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Sphincterotome short-wire compatible

Micro-Tech (Nanjing) Co., Ltd. · Model RDSP-0530-122 · UDI-DI 06932503575331

KNS Prescription

510(k) clearances

17,379

Adverse events (81 deaths)

121

Recalls

118

Facilities

Description

Sphincterotome / short-wire compatible, lumen 3, TIP length 5mm, cutting wire 30mm, Outside diameter 2.5mm, Cone, no half Insulation, preload 2.6m guidewire, Weave Cutting wire

Recalls

Date	Firm	Reason
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.