FDC — Resectoscope, Working Element Class II
FDA product code FDC covers "Resectoscope, Working Element", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FDC
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K021166 | acmi-circon corporation | ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR | May 9, 2002 |
| K992141 | olympus winter and ibe | OLYMPUS WORKING ELEMENT FOR PROBES | September 29, 1999 |
| K991426 | mahe intl | MAHE INSTRUMENTS | August 5, 1999 |
| K942626 | gm engineering | CONTINUOUS FLOW BIOPSY PROBE | May 30, 1995 |
| K933962 | gm engineering | GM CONTINUOUS FLOW BIOPSY PROBE | February 25, 1994 |
| K895643 | orthoconcept | MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM | October 17, 1989 |
| K894363 | orthoconcept | UROPUMP* FLUID MANAGEMENT SYSTEM | August 11, 1989 |
| K842997 | laser industries | LASER RECTOSCOPE SET 784 | August 27, 1984 |
| K760184 | v. mueller o.v. baxter healthcare | ELEMENT, WORKING | December 2, 1976 |
| K760182 | v. mueller o.v. baxter healthcare | SHEATH, RESECTOSCOPE | December 2, 1976 |
| K760174 | v. mueller o.v. baxter healthcare | ADAPTER, RESECTOSCOPE | August 30, 1976 |