Maloney Bouge (1210-XX)/HURST Bougie (1212-XX)
FDA 510(k) K972119 · Medovations, Inc.
510(k) numberK972119
Submission
- Device name
- Maloney Bouge (1210-XX)/HURST Bougie (1212-XX)
- Applicant
- Medovations, Inc.
Germantown, WI, US - Received
- June 5, 1997
- Decision date
- February 2, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K843186 | Eska Multistage Esophageal BougieFAT · Traditional | Dacomed Corp. | 01/18/1985SE |
| 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 |
|---|---|---|
| K142068 | Bulldog Biopsy Valve, Olympus and Fujinon;Pentax Compatible;Disposable Rrigating…OCX · Traditional | 03/10/2015SE |
| K002363 | Medovations Esophageal DilatorKNQ · Traditional | 11/01/2000SE |
| K924646 | Over the Guidewire Dilatation SystemKNQ · Traditional | 12/05/1994SE |
| K913678 | Trocar CatheterKGY · Traditional | 12/16/1991SE |
| K905478 | Yankauer Suction DeviceMDM · Traditional | 12/19/1990SE |
| K874309 | Urethal CatheterKNX · Traditional | 12/07/1987SE |
| K864963 | Stomach Evaculator - Ewald StyleKOA · Traditional | 10/14/1987SE |
| K864962 | Oberto Mouth PropJXL · Traditional | 02/19/1987SE |
| K864964 | 5 - in - 1 ConnectorGAZ · Traditional | 01/20/1987SE |
| K854616 | Enteral Feeding BagKNT · Traditional | 01/23/1986SE |
Questions and answers
When was Maloney Bouge (1210-XX)/HURST Bougie (1212-XX) cleared by the FDA?
Maloney Bouge (1210-XX)/HURST Bougie (1212-XX) (K972119) received a 510(k) decision of Substantially Equivalent on February 2, 1998, 242 days after the submission was received.
What is the product code of K972119?
The FDA product code is FAT – Bougie, Esophageal, And Gastrointestinal, Gastro-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.5365.