The Lahr Balloon
FDA 510(k) K870019 · Plasco, Inc.
510(k) numberK870019
Submission
- Device name
- The Lahr Balloon
- Applicant
- Plasco, Inc.
Gurnee, IL, US - Received
- January 2, 1987
- Decision date
- April 1, 1987
- 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 |
|---|---|---|
| K980066 | CPR FiltershieldBTM · Traditional | 07/16/1998SE |
| K953414 | CPR Micromask with Oxygen InletCBP · Traditional | 03/20/1996SE |
| K951483 | CPR MicromaskCBP · Traditional | 10/19/1995SE |
| K950770 | CPR Microshield IICBP · Traditional | 03/10/1995SE |
| K950769 | CPR Micromask Plus Catalog No 73-402CBP · Traditional | 03/10/1995SE |
| K943386 | CPR MicromaskCBP · Traditional | 02/21/1995SE |
| K932649 | PharmafeedKPE · Traditional | 11/16/1993SE |
| K880337 | Macbick Disposable Barium Enema Syst 4800 & 4700FCE · Traditional | 04/14/1988SE |
| K870623 | Enteral Administration SetFPD · Traditional | 06/26/1987SE |
| K870796 | Macbick-Xl Basic Air Contast Barium Enema Deliv SyFCE · Traditional | 04/01/1987SE |
Questions and answers
When was The Lahr Balloon cleared by the FDA?
The Lahr Balloon (K870019) received a 510(k) decision of Substantially Equivalent on April 1, 1987, 89 days after the submission was received.
What is the product code of K870019?
The FDA product code is FCE – Enema Kit, a Class I (low risk) device regulated under 21 CFR 876.5210.