Enema Kit
FDA 510(k) K761167 · American Hospital Supply Corp.
510(k) numberK761167
Submission
- Device name
- Enema Kit
- Applicant
- American Hospital Supply Corp.
Mchenry, IL, US - Received
- December 1, 1976
- Decision date
- December 9, 1976
- 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 |
|---|---|---|
| K854739 | American Sterile Surgical Absorbent Towel · Traditional | 12/27/1985SE |
| K854759 | American Sterile Mayo Stand Tray · Traditional | 12/17/1985SE |
| K832826 | Aap Dosimetry Release or Basin SetsFNY · Traditional | 04/23/1984SE |
| K830546 | Dosimetric ReleaseKQT · Traditional | 05/25/1983SE |
| K822990 | Convertors Primary Wound Dressing IIFRO · Traditional | 04/12/1983SE |
| K830343 | Container W/Priming SolutionKDP · Traditional | 03/17/1983SE |
| K830301 | Stratus Fluorometric Enzyme IMMUN0-JJE · Traditional | 02/25/1983SE |
| K822755 | Latex Penrose Tubing · Traditional | 01/21/1983SE |
| K823418 | Heyer-Schute Universal Ureteral StentLJE · Traditional | 12/03/1982SE |
| K822966 | Convertors Disposable Dressing SpongeNAB · Traditional | 11/05/1982SE |
Questions and answers
When was Enema Kit cleared by the FDA?
Enema Kit (K761167) received a 510(k) decision of Substantially Equivalent on December 9, 1976, 8 days after the submission was received.
What is the product code of K761167?
The FDA product code is FCE – Enema Kit, a Class I (low risk) device regulated under 21 CFR 876.5210.