Bougie, Filiform, Jackson
FDA 510(k) K770959 · V. Mueller O.V. Baxter Healthcare Corp.
510(k) numberK770959
Submission
- Device name
- Bougie, Filiform, Jackson
- Applicant
- V. Mueller O.V. Baxter Healthcare Corp.
Mchenry, IL, US - Received
- May 27, 1977
- Decision date
- June 14, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KBI – Bougie, Eustachian
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4175
- Specialty
- Ear, Nose, Throat
More from V. Mueller O.V. Baxter Healthcare Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K803292 | Field Suction DissectorGDI · Traditional | 01/29/1981SE |
| K792383 | Kelman DipstickHOE · Traditional | 12/11/1979SE |
| K771197 | Norton EndotrachealBTR · Traditional | 08/16/1977SE |
| K771302 | Pfister-Schwartz Stone RetrieverFGO · Traditional | 08/02/1977SE |
| K770280 | Cord, Electrosurgical-Sterile & Dispos.KNS · Traditional | 04/15/1977SE |
| K760851 | Converse Altar RetractorKAL · Traditional | 03/10/1977SE |
| K761242 | Teflon Coated Resectoscope SheathFJL · Traditional | 12/16/1976SE |
| K760273 | LithotriteFGK · Traditional | 12/06/1976SE |
| K760189 | Stopcock, WaterlineFAJ · Traditional | 12/02/1976SE |
| K760184 | Element, WorkingFDC · Traditional | 12/02/1976SE |
Questions and answers
When was Bougie, Filiform, Jackson cleared by the FDA?
Bougie, Filiform, Jackson (K770959) received a 510(k) decision of Substantially Equivalent on June 14, 1977, 18 days after the submission was received.
What is the product code of K770959?
The FDA product code is KBI – Bougie, Eustachian, a Class I (low risk) device regulated under 21 CFR 874.4175.