Acmi Bipolar Rectoscope, Model Eiwe-Br
FDA 510(k) K021166 · Acmi-Circon Corporation
510(k) numberK021166
Submission
- Device name
- Acmi Bipolar Rectoscope, Model Eiwe-Br
- Applicant
- Acmi-Circon Corporation
Southborough, MA, US - Received
- April 11, 2002
- Decision date
- May 9, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| 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 |
| K760184 | Element, WorkingFDC · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 12/02/1976SE |
| 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 |
Questions and answers
When was Acmi Bipolar Rectoscope, Model Eiwe-Br cleared by the FDA?
Acmi Bipolar Rectoscope, Model Eiwe-Br (K021166) received a 510(k) decision of Substantially Equivalent on May 9, 2002, 28 days after the submission was received.
What is the product code of K021166?
The FDA product code is FDC – Resectoscope, Working Element, a Class II (moderate risk) device regulated under 21 CFR 876.1500.