Enema Set
FDA 510(k) K771792 · Chase Mfg. Co.
510(k) numberK771792
Submission
- Device name
- Enema Set
- Applicant
- Chase Mfg. Co.
Mchenry, IL, US - Received
- September 22, 1977
- Decision date
- October 20, 1977
- 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 |
|---|---|---|
| K791513 | Adamco Dust CoverFRG · Traditional | 10/11/1979SE |
| K790993 | Instant Hot & Cold PacksIMD · Traditional | 09/07/1979SE |
| K790644 | SubmaxDRT · Traditional | 04/26/1979SE |
| K780033 | Mattresses, Conductive & CoversFMW · Traditional | 02/21/1978SE |
| K771791 | Needle CountingMMK · Traditional | 10/04/1977SE |
| K770900 | Cast BRWM, FractureITM · Traditional | 07/21/1977SE |
| K770899 | Fracture Cast Brace, PolyITM · Traditional | 07/21/1977SE |
| K770898 | Fracture Cast Brace Kit, PlasticHSP · Traditional | 07/21/1977SE |
| K770173 | StockinetteILG · Traditional | 02/08/1977SE |
Questions and answers
When was Enema Set cleared by the FDA?
Enema Set (K771792) received a 510(k) decision of Substantially Equivalent on October 20, 1977, 28 days after the submission was received.
What is the product code of K771792?
The FDA product code is FCE – Enema Kit, a Class I (low risk) device regulated under 21 CFR 876.5210.