Infra Vision Bougie Kit, Infra Vision Esophageal Kit
FDA 510(k) K960173 · Gabriel Medical, Inc.
510(k) numberK960173
Submission
- Device name
- Infra Vision Bougie Kit, Infra Vision Esophageal Kit
- Applicant
- Gabriel Medical, Inc.
North Attleboro, MA, US - Received
- January 16, 1996
- Decision date
- June 27, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K972119 | Maloney Bouge (1210-XX)/HURST Bougie (1212-XX)FAT · Traditional | Medovations, Inc. | 02/02/1998SE |
| 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 |
|---|---|---|
| K945088 | Gabriel Ureteral Illuminator System IIFCS · Traditional | 02/07/1995SE |
| K945297 | Infra Vision Imaging SystemGCJ · Traditional | 12/20/1994SE |
| K940019 | Gabriel Ureteral Illuminator SystemFCS · Traditional | 05/02/1994SE |
| K901385 | Gabriel Medical CLS Thermal RecorderDSF · Traditional | 05/09/1990SE |
Questions and answers
When was Infra Vision Bougie Kit, Infra Vision Esophageal Kit cleared by the FDA?
Infra Vision Bougie Kit, Infra Vision Esophageal Kit (K960173) received a 510(k) decision of Substantially Equivalent on June 27, 1996, 163 days after the submission was received.
What is the product code of K960173?
The FDA product code is FAT – Bougie, Esophageal, And Gastrointestinal, Gastro-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.5365.