Lithotrite
FDA 510(k) K760273 · V. Mueller O.V. Baxter Healthcare Corp.
510(k) numberK760273
Submission
- Device name
- Lithotrite
- Applicant
- V. Mueller O.V. Baxter Healthcare Corp.
Mchenry, IL, US - Received
- July 22, 1976
- Decision date
- December 6, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FGK – Tripsor, Stone, Bladder
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4500
- Specialty
- Gastroenterology, Urology
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 |
| K770959 | Bougie, Filiform, JacksonKBI · Traditional | 06/14/1977SE |
| 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 |
| K760189 | Stopcock, WaterlineFAJ · Traditional | 12/02/1976SE |
| K760184 | Element, WorkingFDC · Traditional | 12/02/1976SE |
Questions and answers
When was Lithotrite cleared by the FDA?
Lithotrite (K760273) received a 510(k) decision of Substantially Equivalent on December 6, 1976, 137 days after the submission was received.
What is the product code of K760273?
The FDA product code is FGK – Tripsor, Stone, Bladder, a Class II (moderate risk) device regulated under 21 CFR 876.4500.