Product code KDH
- Device name
- Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5980
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K983624 | GILTECH PLUS CONNECTING TUBE SET | Giltech Plus, Inc. | 1999-03-18 |
| K981286 | SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS | Armm, Inc. | 1998-06-19 |
| K971259 | COMBIPORT FLUID LAVAGE DEVICE | B.Braun Medical, Inc. | 1997-10-27 |
| K962850 | TUM-E-VAC | Ethox Corp. | 1997-02-21 |
| K951533 | EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT | Ballard Medical Products | 1995-07-05 |
| K923497 | FLUSHING IRRIGATION SET | Orion Life Systems, Inc. | 1994-03-21 |
| K920619 | TRI-MED GASTRIC LAVAGE SYSTEM | Tri-Med Specialties, Inc. | 1992-09-04 |
| K920527 | TRI-MED QUICK-STEP GASTRIC LAVAGE KIT | Tri-Med Specialties, Inc. | 1992-09-04 |
| K914908 | QUICVAGE PLUS | Autovage | 1992-04-13 |
| K914907 | QUICVAGE | Autovage | 1992-01-24 |
| K911788 | ECONOVAGE R | Autovage | 1991-07-26 |
| K911919 | MINIVAGE(R) | Autovage | 1991-07-26 |
| K911324 | IRRIGATION/ASPIRATION TUBING SET | Biomedical Dynamics, Inc. | 1991-06-24 |
| K902421 | STOMACH, GASTRO-ENTEROSTOMY | Gainor Medical Europe, Ltd. | 1990-11-20 |
| K900086 | HEMORRHOIDAL LIGATOR WITH SUCTION | Baxter Healthcare Corp | 1990-03-19 |
| K896573 | EASI-LAV ADULT GASTRIC LAVAGE KIT | Clairson Industries, LLC | 1990-01-29 |
| K892334 | LEONARD TUBE | Surgidyne, Inc. | 1989-05-31 |
| K860599 | ETHOX LAVAGE TUBE | Ethox Corp. | 1986-03-11 |
| K821496 | DISPOSABLE IRRIGA/ASPIR. SYSTEM | Innovative Surgical Products, Inc. | 1982-06-22 |
| K781749 | TUBING, AXIOM SILICONE PENROSE | Axiom Medical, Inc. | 1978-12-04 |
| K770534 | THERAPEUTIC APPARATUS, DIERKER TYPE | Well Being Ent. | 1978-04-21 |
| K770248 | ARGYLE RAPID GASTRIC LAVAGE KIT | Sherwood Medical Industries | 1977-03-09 |
| K760556 | IRRIGATION CATHETER | Sherwood Medical Industries | 1977-02-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10850082007124 | Aspiration Tubing | ARMM INC. | 2023-06-08 |
| 10850082007117 | Aspiration Tubing | ARMM INC. | 2023-06-08 |
| 10850082007100 | Aspiration Tubing | ARMM INC. | 2023-06-08 |
| 30884527000092 | Argyle | Cardinal Health, Inc. | 2016-10-13 |
| 10889483150061 | Ethox Medical | ETHOX MEDICAL, LLC | 2016-09-29 |
| 10889483150054 | Ethox Medical | ETHOX MEDICAL, LLC | 2016-09-29 |
| 10889483150047 | Ethox Medical | ETHOX MEDICAL, LLC | 2016-09-29 |
| 10889483131145 | Ethox Medical | ETHOX MEDICAL, LLC | 2016-09-29 |
| 10889483131138 | Ethox Medical | ETHOX MEDICAL, LLC | 2016-09-29 |
| 10889483130964 | Ethox Medical | ETHOX MEDICAL, LLC | 2016-09-28 |
| 10889483150160 | Ethox Medical | ETHOX MEDICAL, LLC | 2016-09-27 |
| 10889483150078 | Ethox Medical | ETHOX MEDICAL, LLC | 2016-09-27 |
| 10889483131091 | Ethox Medical | ETHOX MEDICAL, LLC | 2016-09-27 |
| 10889483130957 | Ethox Medical | ETHOX MEDICAL, LLC | 2016-09-27 |
| M665101863H0 | Axiom® | AXIOM MEDICAL, INCORPORATED | 2016-09-23 |
| M6651018630 | Axiom® | AXIOM MEDICAL, INCORPORATED | 2016-09-23 |
| M665101850H0 | Axiom® | AXIOM MEDICAL, INCORPORATED | 2016-09-23 |
| M6651018500 | Axiom® | AXIOM MEDICAL, INCORPORATED | 2016-09-23 |
| M665101825H0 | Axiom® | AXIOM MEDICAL, INCORPORATED | 2016-09-23 |
| M6651018250 | Axiom® | AXIOM MEDICAL, INCORPORATED | 2016-09-23 |
| M665101263H0 | Axiom® | AXIOM MEDICAL, INCORPORATED | 2016-09-23 |
| M6651012630 | Axiom® | AXIOM MEDICAL, INCORPORATED | 2016-09-23 |
| M665101250H0 | Axiom® | AXIOM MEDICAL, INCORPORATED | 2016-09-23 |
| M6651012500 | Axiom® | AXIOM MEDICAL, INCORPORATED | 2016-09-23 |
| M665101225H0 | Axiom® | AXIOM MEDICAL, INCORPORATED | 2016-09-23 |
| M6651012250 | Axiom® | AXIOM MEDICAL, INCORPORATED | 2016-09-23 |
| 10680651927740 | Halyard | Avanos Medical, Inc. | 2016-07-06 |
| 10680651927962 | Halyard | Avanos Medical, Inc. | 2016-07-06 |
| 10680651927801 | Halyard | Avanos Medical, Inc. | 2016-07-06 |
| 10680651927757 | Halyard | Avanos Medical, Inc. | 2016-07-06 |