Fujinon Model EG-530N Trans Nasal Insertion
FDA 510(k) K063316 · Fujinon, Inc.
510(k) numberK063316
Submission
- Device name
- Fujinon Model EG-530N Trans Nasal Insertion
- Applicant
- Fujinon, Inc.
Shelton, CT, US - Received
- November 2, 2006
- Decision date
- March 16, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDS – Gastroscope And Accessories, Flexible/Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To examine or perform procedures in the stomach. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code FDS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260856 | Disposable Distal Attachment D-201-13404FDS · Traditional | Olympus Medical Systems Corporation | 08/27/2026SE |
| K260824 | Gastrointestinal Videoscope Olympus GIF-2T1500FDS · Traditional | Olympus Medical Systems Corporation | 08/27/2026SE |
| K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000)FDS · Traditional | Intuitive Surgical, Inc. | 08/07/2026SE |
| K260573 | EvoEndo Single-Use Endoscopy SystemFDS · Traditional | EvoEndo, Inc. | 04/21/2026SE |
| K250550 | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFDS · Traditional | Fujifilm Corporation | 02/17/2026SE |
| K253568 | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood…FDS · Special | Fujifilm Corporation | 02/06/2026SE |
| K251256 | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video…FDS · Traditional | Pentax of America, Inc. | 12/16/2025SE |
| K251041 | GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100FDS · Traditional | Actuated Medical, Inc. | 10/31/2025SE |
| K251708 | EvoEndo Single-Use Endoscopy SystemFDS · Traditional | EvoEndo, Inc. | 10/10/2025SE |
| K243388 | Disposable Distal CapFDS · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 06/27/2025SE |
More from Micro-Tech (Nanjing) Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K120446 | Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2FDS · Traditional | 08/13/2012SE |
| K112391 | Fujinon ColonoscopesFDF · Special | 07/26/2012SE |
| K102466 | Fujinon EPX-4440HD Digital Video ProcessorFET · Traditional | 05/25/2011SE |
| K111243 | Fujinon Ultrasonic ProcessorFDS · Special | 05/16/2011SE |
| K091773 | Fujinon Sterile OvertubesFED · Special | 08/07/2009SE |
| K090116 | Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15FDF · Traditional | 04/22/2009SE |
| K063847 | Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700FDS · Traditional | 03/01/2007SE |
| K050907 | Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270PEOQ · Traditional | 05/19/2005SE |
| K042043 | Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5FDS · Traditional | 11/24/2004SE |
| K042076 | Fujinon G5 Duodenscopes; G5 Duodenoscopes, ED-450XT5, ED-250XT5FDT · Traditional | 11/18/2004SE |
Questions and answers
When was Fujinon Model EG-530N Trans Nasal Insertion cleared by the FDA?
Fujinon Model EG-530N Trans Nasal Insertion (K063316) received a 510(k) decision of Substantially Equivalent on March 16, 2007, 134 days after the submission was received.
What is the product code of K063316?
The FDA product code is FDS – Gastroscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.