FUJIFILM Bronchoscope
510(k) K183607
FUJIFILM Bronchoscope is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K183607 on 23 Aug 2019, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK183607 | Date23 Aug 2019 | StatusActive |
Official records
- FDA 510(k) database K183607
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EOQ
- Device class
- Class II
- Regulation
- 21 CFR Part 874.4680
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K183607
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| FUJIFILM EB-580S | EB-580S | 04547410400380 | — | On the market |
| FUJIFILM EB-580T | EB-580T | 04547410400397 | — | On the market |
Similar devices
Other devices filed under FDA product code EOQ (Bronchoscope (Flexible Or Rigid)).
- PENTAX Medical Video Bronchoscopes by PENTAX of America Inc.
- 10315N by Karl Storz SE & CO. KG
- PENTAX Medical Video Bronchoscope EB-J10 Series by PENTAX of America Inc.
- FUJIFILM Endoscope Model EB-710XT by FUJIFILM Healthcare Americas Corporation
- ENK FIBEROPTIC ATOMIZER SET by Cook, Inc.
- MiiS Horus scope 5007 by Medimaging Integrated Solution, Inc (Miis)
- TBAN by Boston Scientific
- Ion Endoluminal System (IF1000) by Intuitive Surgical, Inc.
- VB-1830/VB-1530, VIDEO BRONCHOSCOPE by Pentax Precision Instrument Corp.
- WANG BRONCHIAL NEEDLE BRUSH by Mill-Rose Laboratory