510(k) K060923
- Device
- NAVIAID BGE DEVICE, MODEL 21-001
- Applicant
- SMART MEDICAL SYSTEMS, LTD.
- 510(k) number
- K060923
- Product code
- FDA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-08-15
- Date received
- 2006-04-04
- Regulation
- 876.1500
- Classification name
- Enteroscope And Accessories
- 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
- AHAVA STEIN
- Address
- 20 Hata'As St., Suite 213 Beit Hapa'Amon, Box 124 Kfar Saba IL 44425 44425
FDA Registration Numbers#
- 3000308637
- 3029545567
- 1000513161
- 3042225166
- 3008386005
- 8010047
- 3011050570
- 3042172882
- 3003775006
- 3017140456
- 3002808148
- 3010188783
- 3005814162
- 3006161756
- 9610595
- 3015136743
- 3004052101
- 1222928
Source Documents#
Other 510(k) Records For Product Code FDA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260314 | Ancora-SB | Aspero Medical, Inc. | 2026-05-01 |
| K251204 | FUJIFILM Stiffening Wire Device (SW-2000) | FUJIFILM Healthcare Americas Corporation | 2025-09-26 |
| K233321 | Double Balloon Endoscope EN-840T, Over-tube TS-1214C | FUJIFILM Healthcare Americas Corporation | 2024-06-13 |
| K231323 | Ancora-SB | Aspero Medical, Inc. | 2023-08-31 |
| K223295 | Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D | Fujifilm Corporaton | 2023-01-11 |
| K213195 | Balloon BS-3 | Fujifilm Corporation | 2021-10-29 |
| K191330 | Arc Enterocuff | Boddingtons Plastics, Ltd. | 2020-01-31 |
| K183032 | FUJIFILM Double Balloon Endoscope EI580BT | Fujifilm Corporation | 2019-06-24 |
| K183683 | FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 | Fujifilm Corporation | 2019-02-27 |
| K143556 | Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T | Fujifilm Medical Systems U.S.A, Inc. | 2015-08-20 |
| K071254 | SMALL INTESTINAL VIDEOSCOPE SYSTEM | Olympus Medical Systems Corporation | 2008-03-25 |
| K060235 | ENDO-EASE ENDOSCOPIC OVERTUBE | Spirus Medical, Inc. | 2006-08-04 |
| K040048 | FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM | Fujinon, Inc. | 2004-06-07 |
| K031256 | XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE | Olympus Opto-Electronics Co., Ltd. | 2003-07-23 |
| K993704 | GASTRO-INTESTINAL SYSTEM EN-410WM | Fujinon, Inc. | 2000-02-11 |
Legacy Summary#
summary
FDA Review#
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