Distender Series II Barostat
FDA 510(k) K991288 · G & J Electronics, Inc.
510(k) numberK991288
Submission
- Device name
- Distender Series II Barostat
- Applicant
- G & J Electronics, Inc.
Toronto, Ontario, CA - Received
- April 14, 1999
- Decision date
- June 8, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FFX – System, Gastrointestinal Motility (Electrical)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1725
- Specialty
- Gastroenterology, Urology
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| K223705 | EndoflipTM 300FFX · Traditional | Covidien, LLC | 04/14/2023SE |
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| K201106 | IntraMarX 3D Radiopaque MarkerFFX · Special | Anx Robotica Corp | 05/21/2020SE |
| K191087 | IntraMarX Radiopaque MarkersFFX · Traditional | Anx Robotica Corp | 12/18/2019SE |
| K190208 | Diversatek Healthcare High Resolution Impedance Manometry (HRiM) ProbeFFX · Traditional | Diversatek Healthcare | 10/03/2019SE |
| K181760 | Transit-PelletsFFX · Traditional | Medifactia AB | 08/08/2019SE |
| K183072 | EndoFLIP SystemFFX · Traditional | Crospon, Ltd. | 02/15/2019SE |
More from Crospon, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K973844 | Gastric and Rectal CathetersFFX · Traditional | 06/04/1999SE |
Questions and answers
When was Distender Series II Barostat cleared by the FDA?
Distender Series II Barostat (K991288) received a 510(k) decision of Substantially Equivalent on June 8, 1999, 55 days after the submission was received.
What is the product code of K991288?
The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.