Enema Bag Set
FDA 510(k) K901182 · Orion Life Systems, Inc.
510(k) numberK901182
Submission
- Device name
- Enema Bag Set
- Applicant
- Orion Life Systems, Inc.
Wheeling, IL, US - Received
- March 13, 1990
- Decision date
- June 28, 1990
- Decision
- Unknown (SESK)
- 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 |
| 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 |
|---|---|---|
| K943835 | Pre-Filled Syringe W/Sterile .25% Acetc AcidKNY · Traditional | 01/24/1995SE |
| K943836 | Pre-Filled 10CC Inflation Syringe W/Sterile WaterJOL · Traditional | 11/21/1994SE |
| K943834 | Sterile .9% Sodium Chloride SolutionJOL · Traditional | 11/21/1994SE |
| K943832 | Sterile .9% Sodium Chloride for IrrationJOL · Traditional | 11/21/1994SE |
| K943831 | Pre-Filled 30CC Inflation Syringe W/Sterile WaterJOL · Traditional | 11/21/1994SE |
| K943830 | Pre-Filled Syringe W/Sterile 0.9% Sodium Chloride SolutionJOL · Traditional | 11/21/1994SE |
| K943829 | Pre-Filled Sysringe W/Sterile WaterJOL · Traditional | 11/21/1994SE |
| K943828 | Sterile Water for IrrigationJOL · Traditional | 11/21/1994SE |
| K943833 | Sterile Water for IrrationJOL · Traditional | 11/01/1994SE |
| K923168 | Dual Port Enteral Y-AdaptorKNT · Traditional | 06/17/1994SE |
Questions and answers
When was Enema Bag Set cleared by the FDA?
Enema Bag Set (K901182) received a 510(k) decision of Unknown on June 28, 1990, 107 days after the submission was received.
What is the product code of K901182?
The FDA product code is FCE – Enema Kit, a Class I (low risk) device regulated under 21 CFR 876.5210.