Easi-Lav Pediatric / Adult Gastric Lavage Kit
FDA 510(k) K951533 · Ballard Medical Products
510(k) numberK951533
Submission
- Device name
- Easi-Lav Pediatric / Adult Gastric Lavage Kit
- Applicant
- Ballard Medical Products
Draper, UT, US - Received
- April 3, 1995
- Decision date
- July 5, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KDH – Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KDH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K983624 | Giltech Plus Connecting Tube SetKDH · Traditional | Giltech Plus, Inc. | 03/18/1999SE |
| K981286 | Superflow Irrigation and Aspiration Tubing SetsKDH · Traditional | Armm, Inc. | 06/19/1998SE |
| K971259 | Combiport Fluid Lavage DeviceKDH · Traditional | B.Braun Medical, Inc. | 10/27/1997SE |
| K962850 | Tum-E-VacKDH · Traditional | Ethox Corp. | 02/21/1997SE |
| K923497 | Flushing Irrigation SetKDH · Traditional | Orion Life Systems, Inc. | 03/21/1994SESK |
| K920619 | Tri-Med Gastric Lavage SystemKDH · Traditional | Tri-Med Specialties, Inc. | 09/04/1992SE |
| K920527 | Tri-Med Quick-Step Gastric Lavage KitKDH · Traditional | Tri-Med Specialties, Inc. | 09/04/1992SE |
| K914908 | Quicvage PlusKDH · Traditional | Autovage | 04/13/1992SESK |
| K914907 | QuicvageKDH · Traditional | Autovage | 01/24/1992SE |
| K911919 | Minivage(R)KDH · Traditional | Autovage | 07/26/1991SE |
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| K022398 | Reusable Bronchial Biopsy ForcepsBWH · Traditional | 10/11/2002SE |
| K013892 | Lutz NeedleBSP · Traditional | 07/11/2002SE |
| K000495 | Ballard Medical Products Epidural and Spinal NeedlesBSP · Traditional | 03/28/2000SE |
| K993138 | Ballard Mic-Key G Low Profile Gastrostomy Replacement KitKNT · Special | 10/20/1999SE |
| K990376 | Ballard Medical Products Faciletome Bow String PapillotomeKNS · Traditional | 05/03/1999SE |
| K982894 | Mic-Key Glow Profile Gastrostomy Replacement KitKNT · Special | 09/11/1998SE |
| K974630 | 72 Hour Use Trach Care with MicrobanCAH · Traditional | 03/11/1998SE |
| K964369 | Trach Care Set with MicrobanBSY · Traditional | 02/11/1997SE |
| K923487 | Bal CathKTR · Traditional | 07/30/1993SESK |
Questions and answers
When was Easi-Lav Pediatric / Adult Gastric Lavage Kit cleared by the FDA?
Easi-Lav Pediatric / Adult Gastric Lavage Kit (K951533) received a 510(k) decision of Substantially Equivalent on July 5, 1995, 93 days after the submission was received.
What is the product code of K951533?
The FDA product code is KDH – Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration, a Class II (moderate risk) device regulated under 21 CFR 876.5980.