MS Classique Balloon Catheter
FDA 510(k) K944143 · Meadox Surgimed, Inc.
510(k) numberK944143
Submission
- Device name
- MS Classique Balloon Catheter
- Applicant
- Meadox Surgimed, Inc.
Oakland, NJ, US - Received
- August 25, 1994
- Decision date
- March 13, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FGE – Stents, Drains And Dilators For The Biliary Ducts
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5010
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
- Life-sustaining
- Yes
Other 510(k)s with product code FGE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260835 | ARCHIMEDES Biodegradable Stent (Medium)FGE · Traditional | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 07/27/2026SE |
| K253393 | Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018…FGE · Traditional | Hangzhou AGS MedTech Co., Ltd. | 06/24/2026SE |
| K253832 | Dilation Balloon CatheterFGE · Traditional | Mirco-Tech (Nanjing) Co., Ltd. | 04/24/2026SE |
| K251658 | Endoflux Biliary & Pancreatic Stent SetsFGE · Traditional | Medi-Globe GmbH | 04/16/2026SE |
| K253987 | BARE Wireguided Balloon Dilation Catheter (1235)FGE · Traditional | GIE Medical | 03/13/2026SE |
| K253132 | Single use stone retrieval balloonsFGE · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 03/06/2026SE |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M StentFGE · Traditional | Taewoong Medical Co., Ltd. | 12/29/2025SESU |
| K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-GFGE · Traditional | Bioteque Corporation | 12/22/2025SE |
| K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable…FGE · Traditional | Olympus Medical Systems Corporation | 10/21/2025SE |
| K251229 | EndoFixTissue Fixation SystemFGE · Traditional | Softac Medical Technologies | 08/20/2025SE |
More from Softac Medical Technologies
| 510(k) | Device | Decision |
|---|---|---|
| K945061 | Noprofile Olbert Catheter SystemKOD · Traditional | 03/09/1995SE |
| K942382 | MS Amplatz Extra Stiff Guide WireDQX · Traditional | 08/22/1994SE |
| K930201 | Acecut Sutomatic Biopsy SystemKNW · Traditional | 06/09/1993SE |
| K911635 | Meadox(R) Surgimed(R) Biopsy Gun IIKNW · Traditional | 06/20/1991SE |
| K905181 | No Profile Olbert Catheter System for UrologyEZN · Traditional | 03/06/1991SE |
| K904582 | Quickwire - Hydrophilic Coated GuidewireDQX · Traditional | 02/25/1991SE |
| K904983 | Meadox(R) Surgimed Olbert Cath Syst for UrologyEZN · Traditional | 01/30/1991SE |
| K902461 | Meadox Surgimed Biopsy Gun and NeedleKNW · Traditional | 07/16/1990SE |
| K890926 | Surecut BMB Bone Marrow Biopsy/Aspiration NeedleFMI · Traditional | 06/20/1989SE |
| K863218 | Cytostatic Filtration SetLFK · Traditional | 02/12/1987SE |
Questions and answers
When was MS Classique Balloon Catheter cleared by the FDA?
MS Classique Balloon Catheter (K944143) received a 510(k) decision of Substantially Equivalent on March 13, 1995, 200 days after the submission was received.
What is the product code of K944143?
The FDA product code is FGE – Stents, Drains And Dilators For The Biliary Ducts, a Class II (moderate risk) device regulated under 21 CFR 876.5010.