Gent-L-Kare Cleansing Enema Set
FDA 510(k) K881218 · Geneva Laboratories, Inc.
510(k) numberK881218
Submission
- Device name
- Gent-L-Kare Cleansing Enema Set
- Applicant
- Geneva Laboratories, Inc.
Elkhorn, WI, US - Received
- March 22, 1988
- Decision date
- July 28, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FCE – Enema Kit
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5210
- Specialty
- Gastroenterology, Urology
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.
Other 510(k)s with product code FCE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974042 | Amsure Cleansing Enema SetFCE · Traditional | Amsino Intl., Inc. | 12/19/1997SE |
| K931896 | Pro-Flo SystemFCE · Traditional | Lafayette Pharmacal, Inc. | 08/26/1993SE |
| K922398 | 4 Sure TM Enema Bag SetFCE · Traditional | Boston Pacific Medical, Inc. | 06/17/1993SEKD |
| K913620 | Enema KitFCE · Traditional | York County Blind Center | 11/01/1991SESK |
| K904534 | Enema BulbFCE · Traditional | R.A.C., Inc. | 12/21/1990SE |
| K901182 | Enema Bag SetFCE · Traditional | Orion Life Systems, Inc. | 06/28/1990SESK |
| K901179 | Enema Bucket SetFCE · Traditional | Orion Life Systems, Inc. | 06/28/1990SESK |
| K900848 | Enema Kit 'Straight' DesignFCE · Traditional | Custom Medical Products, Ltd. | 04/13/1990SE |
| K900847 | Enema Kit 'Y' DesignFCE · Traditional | Custom Medical Products, Ltd. | 04/13/1990SE |
| K880337 | Macbick Disposable Barium Enema Syst 4800 & 4700FCE · Traditional | Plasco, Inc. | 04/14/1988SE |
More from Plasco, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K881217 | Gent-L-Kare Sterile Urinary Leg BagKNX · Traditional | 07/29/1988SE |
| K881213 | Gent-L-Kare Sterile Urinary Drainage Bag CenterKNX · Traditional | 07/28/1988SE |
| K881216 | Gent-L-Kare Vaginal Irrigation SetHED · Traditional | 06/07/1988SE |
| K861308 | Accupac Custom Pack Kerlix SquaresEFQ · Traditional | 05/02/1986SE |
| K861219 | Accupac Custom Skin Scrub Kit · Traditional | 04/15/1986SE |
| K853265 | Accupac Custom Operating Room PROCEDURE-DK876543 · Traditional | 08/26/1985SE |
| K843206 | Cook County Hospital Dressing Change SetKDD · Traditional | 05/24/1985SE |
| K844255 | Gent-L-Kare Sterile I.V. Start KitFPA · Traditional | 12/19/1984SE |
| K843090 | University of Chicago Vascular AngiogramFPA · Traditional | 12/04/1984SE |
| K830725 | Gent-L-Spec Dispos. Vaginal SpeculumHIB · Traditional | 04/27/1983SE |
Questions and answers
When was Gent-L-Kare Cleansing Enema Set cleared by the FDA?
Gent-L-Kare Cleansing Enema Set (K881218) received a 510(k) decision of Substantially Equivalent on July 28, 1988, 128 days after the submission was received.
What is the product code of K881218?
The FDA product code is FCE – Enema Kit, a Class I (low risk) device regulated under 21 CFR 876.5210.