4 Sure TM Enema Bag Set
FDA 510(k) K922398 · Boston Pacific Medical, Inc.
510(k) numberK922398
Submission
- Device name
- 4 Sure TM Enema Bag Set
- Applicant
- Boston Pacific Medical, Inc.
Boston, MA, US - Received
- May 21, 1992
- Decision date
- June 17, 1993
- Decision
- Unknown (SEKD)
- 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 |
|---|---|---|---|
| K974042 | Amsure Cleansing Enema SetFCE · Traditional | Amsino Intl., Inc. | 12/19/1997SE |
| K931896 | Pro-Flo SystemFCE · Traditional | Lafayette Pharmacal, Inc. | 08/26/1993SE |
| 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 |
|---|---|---|
| K933109 | 4SURE Uro-Link Urological Procedure TraysKOD · Traditional | 03/28/1994SEKD |
| K922402 | 4 Sure TM Enteral Feeding BagFPD · Traditional | 03/25/1994SE |
| K931048 | 4-SURE Nelaton CatheterEZD · Traditional | 02/14/1994SE |
| K931047 | 4-SURE Female CatheterEZD · Traditional | 02/14/1994SE |
| K921852 | 4 Sure TM Rectal TubeKMO · Traditional | 10/08/1993SE |
| K921853 | 4 Sure TM Feeding TubesKNT · Traditional | 07/13/1993SE |
| K921851 | 4 Sure TM Suction Catheters & KitsBSY · Traditional | 07/07/1993SESK |
| K922397 | 4 Sure TM Nasal Oxygen CannulaCAT · Traditional | 03/18/1993SE |
| K924995 | 4 Sure TM Anesthesia Extension SetBSO · Traditional | 12/30/1992SE |
| K922401 | 4 Sure TM Colostomy PouchEZQ · Traditional | 06/10/1992SE |
Questions and answers
When was 4 Sure TM Enema Bag Set cleared by the FDA?
4 Sure TM Enema Bag Set (K922398) received a 510(k) decision of Unknown on June 17, 1993, 392 days after the submission was received.
What is the product code of K922398?
The FDA product code is FCE – Enema Kit, a Class I (low risk) device regulated under 21 CFR 876.5210.