FDE — Laparoscopy Kit Class II
Classification Details
- Product Code
- FDE
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K955717 | mitsubishi cable america | ENDOSCOPE INTRODUCER KIT | April 18, 1996 |
| K950924 | aslan medical technologies | ASLAN KNOT PUSHER | March 14, 1995 |
| K942677 | boston scientific | GEENEN/ZEBRA GUIDELINES | July 21, 1994 |
| K912443 | candela laser | CANDELA INTRODUCER SHEATH SYSTEM | August 16, 1991 |