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510(k) K251997

Single-Use Biopsy Valve (MAJ-1555) by Olympus Medical Systems Corporation — Product Code OCX

K251997 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corporation for the device "Single-Use Biopsy Valve (MAJ-1555)". The FDA issued a decision of Substantially Equivalent on September 25, 2025. The device falls under product code OCX (Endoscopic Irrigation/Suction System), a Class II device regulated under 21 CFR 876.1500. Olympus Medical Systems Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2025
Date Received
June 27, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Irrigation/Suction System
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.

Other clearances by Olympus Medical Systems Corporation

  • K261260 — HD Camera Head OLYMPUS CH-S200-08-LB (June 24, 2026)
  • K252050 — Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D (March 20, 2026)
  • K250993 — Single Use Cytology Brush V (BC-V600P-3010) (December 18, 2025)
  • K252889 — Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) (November 25, 2025)
  • K250409 — Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disp (October 21, 2025)
  • K252247 — Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use (October 16, 2025)
  • K250351 — Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical (October 10, 2025)
  • K252150 — Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); (October 7, 2025)
  • K250187 — Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) (October 7, 2025)
  • K251859 — EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) (October 3, 2025)

Other clearances for product code OCX

  • K251986 — AUXILIARY WATER TUBE MAJ-855 (September 26, 2025)
  • K242586 — ArgoCap (200.52) (May 22, 2025)
  • K241704 — Endoscopic Water Pump (March 20, 2025)
  • K242357 — Water Container (MAJ-901); Water Container (MAJ-902) (October 7, 2024)
  • K241874 — Aspiration Catheter (2189) (September 24, 2024)
  • K242134 — ClearCap Distal Attachment (August 20, 2024)
  • K233442 — troCarWash™ System (May 21, 2024)
  • K230773 — Endoscopy Irrigation Tubing (November 21, 2023)
  • K231471 — Air/Water Bottle Tubing, CO2 Source Tubing (September 8, 2023)
  • K231418 — ENDOGATOR™ Hybrid Irrigation Tubing (August 14, 2023)

FDA data resources