510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203166Substantially Equivalent

PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

PENTAX of America, Inc., Montvale NJ / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203166 is the FDA 510(k) clearance record for PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U, a class II device, cleared for Pentax of America, Inc. on under FDA product code ODG (Endoscopic Ultrasound System, Gastroenterology-Urology). FDA's definition for product code ODG reads: "To provide ultrasonic visualization of body cavities that can be accessed by endoscope. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a...". FDA records list 72 510(k) clearances for Pentax of America, Inc., from to . As of , FDA records show no recalls naming K203166.

Clearance record

Decision date
Received
(68 days to decision)
Product code
ODG Endoscopic Ultrasound System, Gastroenterology-Urology
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Pentax of America, Inc. 3 Paragon Dr.,, Montvale NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ODG

Trailing 12 months
2 clearances under product code ODG in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ODG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20261
August 20260
September 20260
October 20260