510(k) K173004
- Device
- SB Soft Hood - Straight Type, SB Soft Hood - Undercut Type
- Applicant
- Sumitomo Bakelite Co., Ltd
- 510(k) number
- K173004
- Product code
- FDS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-05-08
- Date received
- 2017-09-27
- Regulation
- 876.1500
- Classification name
- Gastroscope And Accessories, Flexible/rigid
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Shiro Agehama
- Address
- 5-8, Higashi-Shinagawa 2-Chome Shinagawa-Ku JP 1400002 1400002
FDA Registration Numbers#
- 3009698186
- 3024021261
- 3014769442
- 1450997
- 3010141954
- 3018258446
- 2183744
- 3015223550
- 3013247477
- 3004040397
- 9617070
- 3008797804
- 3010220595
- 3004705634
- 3004837686
- 3014605202
- 3010703925
- 3010288205
- 1000163068
- 3015194986
- 3004644065
- 3015746529
- 3002807310
- 9611112
- 3003790304
- 9610691
- 3015525240
- 1221826
- 3005099803
- 3015131155
- 9610877
- 3042225166
- 3008386005
- 3021246306
- 3004111573
- 3010390468
- 3011816755
- 3011416394
- 3008627763
- 3010707607
- 9614641
- 3011050570
- 8010047
- 3042172882
- 3003775006
- 3003782610
- 3010202439
- 9610617
- 3017140456
- 9611680
- 1649518
- 3012843412
- 3002808148
- 2020550
- 3014342096
- 3010188783
- 3013440400
- 3012494290
- 1528319
- 3013944123
- 3015451828
- 3006161756
- 3009171251
- 9610595
- 3015136743
- 3043226252
- 3015807001
- 3021691063
- 3013023255
Source Documents#
Other 510(k) Records For Product Code FDS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260573 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2026-04-21 |
| K250550 | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit | Fujifilm Corporation | 2026-02-17 |
| K253568 | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR | Fujifilm Corporation | 2026-02-06 |
| K251256 | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) | Pentax of America, Inc. | 2025-12-16 |
| K251041 | GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 | Actuated Medical, Inc. | 2025-10-31 |
| K251708 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2025-10-10 |
| K243388 | Disposable Distal Cap | Micro-Tech (Nanjing) Co., Ltd. | 2025-06-27 |
| K250900 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2025-06-16 |
| K243512 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP | Fujifilm Corporation | 2025-06-10 |
| K242635 | Endoscopic Distal Attachment (AF-D series) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2025-05-30 |
| K250296 | Disposable Distal Attachment D-201 Series | Olympus Medical Systems Corp. | 2025-05-01 |
| K241213 | PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) | Pentax of America, Inc. | 2024-12-06 |
| K242779 | Hood (DH-083ST) | Fujifilm Corporation | 2024-10-11 |
| K240142 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP | Fujifilm Corporation | 2024-09-04 |
| K232997 | EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 | Olympus Medical Systems Corporation | 2024-06-19 |
Legacy Summary#
summary
FDA Review#
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