KDH — Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration Class II
FDA product code KDH covers "Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration", a Class II medical device regulated under 21 CFR 876.5980. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KDH
- Device Class
- Class II
- Regulation Number
- 876.5980
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K983624 | giltech plus | GILTECH PLUS CONNECTING TUBE SET | March 18, 1999 |
| K981286 | armm | SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS | June 19, 1998 |
| K971259 | b.braun medical | COMBIPORT FLUID LAVAGE DEVICE | October 27, 1997 |
| K962850 | ethox | TUM-E-VAC | February 21, 1997 |
| K951533 | ballard medical products | EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT | July 5, 1995 |
| K923497 | orion life systems | FLUSHING IRRIGATION SET | March 21, 1994 |
| K920527 | tri-med specialties | TRI-MED QUICK-STEP GASTRIC LAVAGE KIT | September 4, 1992 |
| K920619 | tri-med specialties | TRI-MED GASTRIC LAVAGE SYSTEM | September 4, 1992 |
| K914908 | autovage | QUICVAGE PLUS | April 13, 1992 |
| K914907 | autovage | QUICVAGE | January 24, 1992 |
| K911919 | autovage | MINIVAGE(R) | July 26, 1991 |
| K911788 | autovage | ECONOVAGE R | July 26, 1991 |
| K911324 | biomedical dynamics | IRRIGATION/ASPIRATION TUBING SET | June 24, 1991 |
| K902421 | gainor medical europe | STOMACH, GASTRO-ENTEROSTOMY | November 20, 1990 |
| K900086 | baxter healthcare | HEMORRHOIDAL LIGATOR WITH SUCTION | March 19, 1990 |
| K896573 | clairson industries | EASI-LAV ADULT GASTRIC LAVAGE KIT | January 29, 1990 |
| K892334 | surgidyne | LEONARD TUBE | May 31, 1989 |
| K860599 | ethox | ETHOX LAVAGE TUBE | March 11, 1986 |
| K821496 | innovative surgical products | DISPOSABLE IRRIGA/ASPIR. SYSTEM | June 22, 1982 |
| K781749 | axiom medical | TUBING, AXIOM SILICONE PENROSE | December 4, 1978 |