Product code KDH— Gastroenterology, Urology
ARGYLE RAPID GASTRIC LAVAGE KIT
- Classification name
- Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 23
- First cleared
- Most recent
Market context for product code KDH
FDA has cleared devices under product code KDH between 1977 and 1999, filed by 17 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1999
- 1998
- 1997
- 1995
- 1994
- 1992
- 1991
- 1990
- 1989
- 1986
- 1982
- 1978
- 1977
Top applicants under product code KDH
Recent clearances under product code KDH
- K983624 — GILTECH PLUS CONNECTING TUBE SET
- K981286 — SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS
- K971259 — COMBIPORT FLUID LAVAGE DEVICE
- K962850 — TUM-E-VAC
- K951533 — EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT
- K923497 — FLUSHING IRRIGATION SET
- K920527 — TRI-MED QUICK-STEP GASTRIC LAVAGE KIT
- K920619 — TRI-MED GASTRIC LAVAGE SYSTEM
- K914908 — QUICVAGE PLUS
- K914907 — QUICVAGE
- K911788 — ECONOVAGE R
- K911919 — MINIVAGE(R)
- K911324 — IRRIGATION/ASPIRATION TUBING SET
- K902421 — STOMACH, GASTRO-ENTEROSTOMY
- K900086 — HEMORRHOIDAL LIGATOR WITH SUCTION
- K896573 — EASI-LAV ADULT GASTRIC LAVAGE KIT
- K892334 — LEONARD TUBE
- K860599 — ETHOX LAVAGE TUBE
- K821496 — DISPOSABLE IRRIGA/ASPIR. SYSTEM
- K781749 — TUBING, AXIOM SILICONE PENROSE
- K770534 — THERAPEUTIC APPARATUS, DIERKER TYPE
- K770248 — ARGYLE RAPID GASTRIC LAVAGE KIT
- K760556 — IRRIGATION CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.