Amsure Cleansing Enema Set
FDA 510(k) K974042 · Amsino Intl., Inc.
510(k) numberK974042
Submission
- Device name
- Amsure Cleansing Enema Set
- Applicant
- Amsino Intl., Inc.
Pomona, CA, US - Received
- October 24, 1997
- Decision date
- December 19, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|---|
| 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 |
| K880337 | Macbick Disposable Barium Enema Syst 4800 & 4700FCE · Traditional | Plasco, Inc. | 04/14/1988SE |
More from Plasco, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K070873 | Amsure Bladder Irrigation SetLJH · Traditional | 12/19/2007SE |
| K992719 | Amsure Enteral Delivery Pump Set with SpikeKNT · Traditional | 01/12/2000SE |
| K973107 | Amsino I.V. Administration SetFPA · Traditional | 10/02/1997SE |
| K973199 | Amsino Suction CatheterBSY · Traditional | 09/10/1997SE |
| K971929 | Amsino Urinary Leg BagKNX · Traditional | 08/06/1997SE |
| K964745 | Amsino Urinary Drainage BagKNX · Traditional | 03/18/1997SE |
| K950780 | Amsino Cervical ScraperHHT · Traditional | 07/25/1995SE |
| K951528 | Amsino Disposable Viginal SpeculumHIB · Traditional | 05/11/1995SE |
Questions and answers
When was Amsure Cleansing Enema Set cleared by the FDA?
Amsure Cleansing Enema Set (K974042) received a 510(k) decision of Substantially Equivalent on December 19, 1997, 56 days after the submission was received.
What is the product code of K974042?
The FDA product code is FCE – Enema Kit, a Class I (low risk) device regulated under 21 CFR 876.5210.