Element, Working
FDA 510(k) K760184 · V. Mueller O.V. Baxter Healthcare Corp.
510(k) numberK760184
Submission
- Device name
- Element, Working
- Applicant
- V. Mueller O.V. Baxter Healthcare Corp.
Mchenry, IL, US - Received
- July 6, 1976
- Decision date
- December 2, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FDC – Resectoscope, Working Element
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FDC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K021166 | Acmi Bipolar Rectoscope, Model Eiwe-BrFDC · Special | Acmi-Circon Corporation | 05/09/2002SE |
| K992141 | Olympus Working Element for ProbesFDC · Traditional | Olympus Winter & Ibe GmbH | 09/29/1999SE |
| K991426 | Mahe InstrumentsFDC · Traditional | Mahe Intl., Inc. | 08/05/1999SE |
| K942626 | Continuous Flow Biopsy ProbeFDC · Traditional | Gm Engineering, Inc. | 05/30/1995SE |
| K933962 | GM Continuous Flow Biopsy ProbeFDC · Traditional | Gm Engineering, Inc. | 02/25/1994SE |
| K895643 | Modified Uropump* Fluid Management SystemFDC · Traditional | Orthoconcept, Inc. | 10/17/1989SE |
| K894363 | Uropump* Fluid Management SystemFDC · Traditional | Orthoconcept, Inc. | 08/11/1989SE |
| K842997 | Laser Rectoscope Set 784FDC · Traditional | Laser Industries , Ltd. | 08/27/1984SE |
| K760182 | Sheath, ResectoscopeFDC · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 12/02/1976SE |
| K760174 | Adapter, ResectoscopeFDC · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 08/30/1976SE |
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 |
| K760273 | LithotriteFGK · Traditional | 12/06/1976SE |
| K760189 | Stopcock, WaterlineFAJ · Traditional | 12/02/1976SE |
Questions and answers
When was Element, Working cleared by the FDA?
Element, Working (K760184) received a 510(k) decision of Substantially Equivalent on December 2, 1976, 149 days after the submission was received.
What is the product code of K760184?
The FDA product code is FDC – Resectoscope, Working Element, a Class II (moderate risk) device regulated under 21 CFR 876.1500.