OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT— 510(k) K001203

Clearance details

Applicant

The Olympus Optical Co.

Product code

Code ITX

Device class

Class 2

Regulation

21 CFR 892.1570

Advisory panel

Radiology

Date received

2000-04-13

Decision date

2000-05-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Melville, NY, US

• K261170 — BA-004CC2026-08-12
• K254143 — EM-TECH Passive Ultrasound Probe Strap2026-08-10
• K260161 — SmartGuide Disposable Guides and Grids2026-07-30
• K262474 — ND Needle Guidance System2026-07-27
• K261014 — Accuro® 3S Needle Guide Kit2026-07-24

• K032066 — SONOSURG SYSTEM2003-10-03
• K030194 — XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT2003-03-24
• K021962 — OLYMPUS ULTRASONIC SURGICAL SYSTEM2003-02-12
• K023984 — MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES2003-01-31
• K023272 — DISPOSABLE ASPIRATION NEEDLE NA-200H2002-12-23

Death

6

Injury

137

Malfunction

2,036

Total

2,179

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →