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Endoscope, Ac-Powered And Accessories

FDA product code GCP · Class 2 · Gastroenterology, Urology

285
Registered devices
697
Adverse events
5
Recalls
13
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2024-09-13Olympus Corporation of the AmericasOlympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged
2024-09-13Olympus Corporation of the AmericasProduct being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.
2017-08-18Olympus Corporation of the AmericasOlympus has received complaints about fragments of adhesive which detached from inside the working channel of the referenced products. Cracking, chipping, missi
2017-04-19Olympus Corporation of the AmericasLoop wires breaking at the distal end of the Monopolar HF Resection Electrodes.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.