Pentax of America, Inc. - FDA 510(k) Cleared Devices
44
Total
44
Cleared
0
Denied
FDA 510(k) cleared devices by Pentax of America, Inc. Gastroenterology & Urology ✕
25 devices
Cleared
Dec 16, 2025
PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family)
Gastroenterology & Urology
237d
Cleared
Jun 03, 2025
PENTAX Medical Video Processor (EPK-i8020c)
Gastroenterology & Urology
53d
Cleared
Jan 03, 2025
PENTAX Medical Video Colonoscope (EC38-i20cWL)
Gastroenterology & Urology
168d
Cleared
Dec 06, 2024
PENTAX Medical Video Upper GI Scope (EG27-i20c)
Gastroenterology & Urology
220d
Cleared
Aug 01, 2024
PENTAX Medical Video Duodenoscope (ED34-i10T2s)
Gastroenterology & Urology
231d
Cleared
Dec 01, 2023
PENTAX Medical Gas/Water Feeding Valve OE-B14
Gastroenterology & Urology
126d
Cleared
Jul 28, 2023
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI...
Gastroenterology & Urology
88d
Cleared
Oct 20, 2021
PENTAX Medical Video Upper GI Scopes EG17-J10
Gastroenterology & Urology
271d
Cleared
Oct 01, 2021
PENTAX Medical Auto Leakage Tester SHA-P6
Gastroenterology & Urology
79d
Cleared
May 13, 2021
PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video...
Gastroenterology & Urology
83d
Cleared
Apr 09, 2021
PENTAX Medical Video Duedenoscope ED34-i10T2
Gastroenterology & Urology
30d
Cleared
Apr 01, 2021
Pentax Medical Video Duodenoscope ED32-i10
Gastroenterology & Urology
225d
Cleared
Dec 30, 2020
PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical...
Gastroenterology & Urology
68d
Cleared
Jul 23, 2020
PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound...
Gastroenterology & Urology
189d
Cleared
Dec 20, 2019
PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI...
Gastroenterology & Urology
266d
Cleared
Nov 15, 2019
Pentax Medical Video Duodenoscope ED34-i10T2
Gastroenterology & Urology
88d
Cleared
Nov 12, 2019
PENTAX Medical Video Upper GI Scopes (EG Family)
Gastroenterology & Urology
229d
Cleared
Nov 08, 2019
PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family
Gastroenterology & Urology
179d
Cleared
Jan 18, 2019
PENTAX Video Colonoscopes (EC Family)
Gastroenterology & Urology
269d
Cleared
Aug 21, 2018
PENTAX Medical Endoscopic Ultrasound System
Gastroenterology & Urology
25d
Cleared
Jul 09, 2018
PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video...
Gastroenterology & Urology
28d
Cleared
Jul 03, 2018
PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes
Gastroenterology & Urology
214d
Cleared
Apr 13, 2017
PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope...
Gastroenterology & Urology
224d
Cleared
Nov 24, 2015
PENTAX Medical EPK-i7010 Video Processor with GI Family
Gastroenterology & Urology
259d
Cleared
Jun 22, 2012
PENTAX EPK-I5020 VIDEO PROCESSOR
Gastroenterology & Urology
175d