Pilling Esophageal Bougies
FDA 510(k) K133439 · Teleflexmedical, Inc.
510(k) numberK133439
Submission
- Device name
- Pilling Esophageal Bougies
- Applicant
- Teleflexmedical, Inc.
Durham, NC, US - Received
- November 12, 2013
- Decision date
- June 16, 2014
- 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 |
|---|---|---|---|
| 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 |
| 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 |
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Questions and answers
When was Pilling Esophageal Bougies cleared by the FDA?
Pilling Esophageal Bougies (K133439) received a 510(k) decision of Substantially Equivalent on June 16, 2014, 216 days after the submission was received.
What is the product code of K133439?
The FDA product code is FAT – Bougie, Esophageal, And Gastrointestinal, Gastro-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.5365.