Medical Device Manufacturer · US , Melville , NY

Olympus Medical Systems Corporation - FDA 510(k) Cleared Devices

81 submissions · 81 cleared · Since 2004

81

Total

81

Cleared

0

Denied

FDA 510(k) Regulatory Record - Olympus Medical Systems Corporation Gastroenterology & Urology ✕

46 devices

1-12 of 46

Cleared Dec 18, 2025

Single Use Cytology Brush V (BC-V600P-3010)

Gastroenterology & Urology · 262d

Cleared Nov 25, 2025

Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)

Gastroenterology & Urology · 76d

Cleared Oct 21, 2025

Disposable Balloon Catheter (B5-2Q)

Gastroenterology & Urology · 250d

Cleared Oct 16, 2025

Injector Force Max Single Use Injector (NM-400L)

Gastroenterology & Urology · 90d

Cleared Oct 10, 2025

Single Use Electrosurgical Knife (KD-612L, KD-612U)

Gastroenterology & Urology · 245d

Cleared Oct 07, 2025

Disposable Hot Biopsy Forceps (FD-210U)

Gastroenterology & Urology · 258d

Cleared Oct 03, 2025

EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)

Gastroenterology & Urology · 108d

Cleared Sep 26, 2025

AUXILIARY WATER TUBE MAJ-855

Gastroenterology & Urology · 91d

Cleared Sep 25, 2025

Single-Use Biopsy Valve (MAJ-1555)

Gastroenterology & Urology · 90d

Cleared Jul 16, 2025

Suction Valve (MAJ-1443)

Gastroenterology & Urology · 110d

Cleared May 15, 2025

Colonovideoscope (CF-EZ1500DL)

Gastroenterology & Urology · 90d

Cleared Mar 19, 2025

Luer-Split MAJ-2092

Gastroenterology & Urology · 266d

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