Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
The Esophageal and Gastrointestinal Bougie for Gastro-Urology (product code FAT) is a tapered dilating instrument used to stretch and widen narrowed segments of the esophagus or gastrointestinal tract. It is an FDA Class 2 device (moderate risk), subject to general controls with no 510(k) required under the applicable submission type. It is regulated under 21 CFR 876.5365 in the Gastroenterology and Urology specialty. No special flags apply.
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Basic Information
- Product Code
- FAT
- Device Class
- FDA class 2
- Regulation Number
- 876.5365
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K133439 | PILLING ESOPHAGEAL BOUGIES | Jun 16, 2014 | Substantially Equivalent | Teleflexmedical, Inc. |
| K983220 | STRYKER INFRAVISION ESOPHAGEAL KIT | Jun 04, 1999 | Substantially Equivalent | Stryker Endoscopy |
| K972119 | MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) | Feb 02, 1998 | Substantially Equivalent | Medovations, Inc. |
| K960173 | INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT | Jun 27, 1996 | Substantially Equivalent | Gabriel Medical, Inc. |
| K901425 | PYLORIC BALLOON DILATOR | Jun 21, 1990 | Substantially Equivalent | Telemed Systems, Inc. |
| K843186 | ESKA MULTISTAGE ESOPHAGEAL BOUGIE | Jan 18, 1985 | Substantially Equivalent | Dacomed Corp. |
| K842679 | ESOPHAGEAL DILATOR SET | Oct 02, 1984 | Substantially Equivalent | Mill-Rose Laboratory |
| K780471 | GASTRIC LAVAGE KIT | Jun 02, 1978 | Substantially Equivalent | Gaymar Industries, Inc. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.