American Catheter E.R.C.P. Cannula
FDA 510(k) K940370 · Intl. Medical, Inc.
510(k) numberK940370
Submission
- Device name
- American Catheter E.R.C.P. Cannula
- Applicant
- Intl. Medical, Inc.
Fort Myers, FL, US - Received
- January 26, 1994
- Decision date
- August 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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| 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 |
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| K940335 | American Catheter Poly-SnareFDI · Traditional | 07/21/1994SE |
| K942068 | American Catheter SphincterotomeKNS · Traditional | 06/24/1994SE |
| K930410 | Durham; Luer Lock Extension SetFPA · Traditional | 09/03/1993SE |
| K930406 | Durham; Min Bore Luer Lock Extension SetFPA · Traditional | 09/03/1993SE |
| K923200 | Amcath Disposable Cytology BrushFDX · Traditional | 12/07/1992SE |
| K915142 | Amcath Disposable Biopsy ForcepsFCF · Traditional | 01/10/1992SE |
| K912927 | Amcath Disposable Trocar and Trocar SleeveGCJ · Traditional | 09/19/1991SE |
| K912605 | Amcath Disposable Micro ScissorsGCJ · Traditional | 07/11/1991SE |
Questions and answers
When was American Catheter E.R.C.P. Cannula cleared by the FDA?
American Catheter E.R.C.P. Cannula (K940370) received a 510(k) decision of Substantially Equivalent on August 17, 1994, 203 days after the submission was received.
What is the product code of K940370?
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.