Olympus Medical Systems Corporation - FDA 510(k) Cleared Devices
Recent clearances: Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D, Single Use Cytology Brush V (BC-V600P-3010), Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
81
Total
81
Cleared
0
Denied
FDA 510(k) Regulatory Record - Olympus Medical Systems Corporation Gastroenterology & Urology ✕
46 devices
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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