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Sterile Sphincterotome

Micro-Tech (Nanjing) Co., Ltd. · Model DSP-30505-121221 · UDI-DI 06932503513166

KNS Prescription

510(k) clearances

17,379

Adverse events (81 deaths)

121

Recalls

118

Facilities

Description

Sterile Sphincterotome, lumen 3, TIP length 5, cutting wire 5, Outside diameter 2.5mm, Needle knife, no Rotation, half Insulation, preload guidewire, Single 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.