510(k) K203166
- Device
- 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
- Applicant
- PENTAX Of America, Inc.
- 510(k) number
- K203166
- Product code
- ODG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-12-30
- Date received
- 2020-10-23
- Regulation
- 876.1500
- Classification name
- Endoscopic Ultrasound System, Gastroenterology-urology
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- William Goeller
- Address
- 3 Paragon Dr., Montvale NJ US 07645 07645
FDA Registration Numbers#
- 3003782610
- 3043585886
- 3009526575
- 3042225166
- 9611680
- 9610877
- 8010047
- 3013440400
- 3005580113
- 3002807314
- 3004837686
- 9681260
- 3014579161
- 9614641
- 3008386005
- 3005099803
- 3006161756
- 1225687
- 3043226252
- 3011050570
- 3015924373
- 3017968993
- 3035950510
- 1828132
- 3003637092
- 1000121056
- 3010273872
- 3017140456
- 3007695959
- 3014605202
- 3012494290
- 3002808148
- 3007738736
- 1528319
- 2025773
- 3014769442
- 3042172882
- 2124215
- 9610595
- 3000296634
- 3001845648
Source Documents#
Other 510(k) Records For Product Code ODG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251859 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | Olympus Medical Systems Corporation | 2025-10-03 |
| K251542 | InstaFAN | Onepass Medical , Ltd. | 2025-07-18 |
| K231813 | Ultrasonic Gastrovideoscope | Sonoscape Medical Corp. | 2024-03-08 |
| K232518 | EndoSound Vision System; EVS | Endosound, Inc. | 2023-12-27 |
| K223616 | Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device | Boston Scientific Corporation | 2022-12-30 |
| K221238 | FUJIFILM Ultrasonic Endoscope EG-740UT | Fujifilm Corporation | 2022-08-19 |
| K221952 | Endoscope Model EG-580UT and Endoscope Model EG-580UR | Fujifilm Corporation | 2022-08-04 |
| K214089 | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 | Fujifilm Corporation | 2022-06-03 |
| K212852 | Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-06 |
| K200090 | PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type) | Pentax of America, Inc. | 2020-07-23 |
| K183433 | FUJIFILM Ultrasonic Endoscope | Fujifilm Corporation | 2019-09-05 |
| K182004 | PENTAX Medical Endoscopic Ultrasound System | Pentax of America, Inc. | 2018-08-21 |
| K180731 | Ultramatrix EUS Balloon | United States Endoscopy Group, Inc. (Us Endoscopy) | 2018-04-19 |
| K171207 | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M | Fujifilm Medical Systems U.S.A, Inc. | 2018-01-11 |
| K173184 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | Boston Scientific | 2017-10-27 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases