Enema Container Disp. for Emema Admin.
FDA 510(k) K800961 · The Healthcare Group Laboratories, Inc.
510(k) numberK800961
Submission
- Device name
- Enema Container Disp. for Emema Admin.
- Applicant
- The Healthcare Group Laboratories, Inc.
Mchenry, IL, US - Received
- April 23, 1980
- Decision date
- May 14, 1980
- 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 |
| K881218 | Gent-L-Kare Cleansing Enema SetFCE · Traditional | Geneva Laboratories, Inc. | 07/28/1988SE |
More from Geneva Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K850035 | Empty Solution Transfer ContainerKPE · Traditional | 06/07/1985SE |
| K842170 | Empty Solution Transfer ContainerKPE · Traditional | 10/19/1984SE |
| K842091 | Dispos. Acu-Cut Soft Tissue Biopsy · Traditional | 07/23/1984SE |
| K840742 | Right Atrial CatheterLJS · Traditional | 07/13/1984SE |
| K830299 | Solution Transfer ContainerKPE · Traditional | 02/19/1983SE |
| K822307 | Adhesive Spray #4050-4060KNX · Traditional | 09/24/1982SE |
| K822059 | Show'RbagLGF · Traditional | 07/22/1982SE |
| K821480 | Right Atrial Catheters Parenteral NutritDQY · Traditional | 06/17/1982SE |
| K821230 | Softic 49EBI · Traditional | 05/28/1982SE |
| K821162 | Adhesive RemoverKOX · Traditional | 05/14/1982SE |
Questions and answers
When was Enema Container Disp. for Emema Admin. cleared by the FDA?
Enema Container Disp. for Emema Admin. (K800961) received a 510(k) decision of Substantially Equivalent on May 14, 1980, 21 days after the submission was received.
What is the product code of K800961?
The FDA product code is FCE – Enema Kit, a Class I (low risk) device regulated under 21 CFR 876.5210.