Eska Multistage Esophageal Bougie
FDA 510(k) K843186 · Dacomed Corp.
510(k) numberK843186
Submission
- Device name
- Eska Multistage Esophageal Bougie
- Applicant
- Dacomed Corp.
Minneapolis, MN, US - Received
- August 13, 1984
- Decision date
- January 18, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FAT – Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5365
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FAT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K133439 | Pilling Esophageal BougiesFAT · Traditional | Teleflexmedical, Inc. | 06/16/2014SE |
| K983220 | Stryker Infravision Esophageal KitFAT · Traditional | Stryker Endoscopy | 06/04/1999SE |
| K972119 | Maloney Bouge (1210-XX)/HURST Bougie (1212-XX)FAT · Traditional | Medovations, Inc. | 02/02/1998SE |
| K960173 | Infra Vision Bougie Kit, Infra Vision Esophageal KitFAT · Traditional | Gabriel Medical, Inc. | 06/27/1996SE |
| K901425 | Pyloric Balloon DilatorFAT · Traditional | Telemed Systems, Inc. | 06/21/1990SE |
| K842679 | Esophageal Dilator SetFAT · Traditional | Mill-Rose Laboratory | 10/02/1984SE |
| K780471 | Gastric Lavage KitFAT · Traditional | Gaymar Industries, Inc. | 06/02/1978SE |
More from Gaymar Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K953640 | Duna II Penile ProsthesisFAE · Traditional | 10/27/1995SE |
| K941781 | Rigiscan Plus Rigidity Assessment SystemLIL · Traditional | 08/25/1994SE |
| K920409 | Dacomed Battery Operated Vacuum Erection DeviceLKY · Traditional | 05/11/1992SE |
| K920420 | Dura II Penile ProsthesisFAE · Traditional | 04/16/1992SE |
| K912344 | Modified Duraphase(Tm) Implanted Penile ProsthesisFAE · Traditional | 10/11/1991SE |
| K900774 | Dacomed Negative Pressure Erection DeviceLKY · Traditional | 05/04/1990SE |
| K885323 | Dacomed External Male Continence DeviceFHA · Traditional | 02/08/1989SE |
| K880391 | Dacomed CystometerEXQ · Traditional | 04/27/1988SE |
| K871653 | Duraphase Penile ProsthesisFAE · Traditional | 09/18/1987SE |
| K870320 | Dacomed Penile Prosthesis SizerJLW · Traditional | 03/17/1987SE |
Questions and answers
When was Eska Multistage Esophageal Bougie cleared by the FDA?
Eska Multistage Esophageal Bougie (K843186) received a 510(k) decision of Substantially Equivalent on January 18, 1985, 158 days after the submission was received.
What is the product code of K843186?
The FDA product code is FAT – Bougie, Esophageal, And Gastrointestinal, Gastro-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.5365.