Pigtail Stents
FDA 510(k) K821819 · American Endoscopy, Inc.
510(k) numberK821819
Submission
- Device name
- Pigtail Stents
- Applicant
- American Endoscopy, Inc.
Mchenry, IL, US - Received
- June 21, 1982
- Decision date
- August 20, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K853274 | American Dilatation SystemKNQ · Traditional | 10/17/1985SE |
| K841384 | Proxima 1 PH MonitorFFT · Traditional | 07/19/1984SE |
| K833491 | Endo Bite BlockKTI · Traditional | 04/25/1984SE |
| K840818 | Biopsy ForcepsFCL · Traditional | 04/13/1984SE |
| K833859 | Tamponade Balloon CuffGCP · Traditional | 01/03/1984SE |
| K833492 | Percutaneous Endoscopic GastroscopyKNT · Traditional | 11/29/1983SE |
| K832458 | Automatic EndoscopeNVE · Traditional | 10/20/1983SE |
| K821818 | Retrieval BalloonsKOD · Traditional | 09/24/1982SE |
| K822062 | Ball Tip Coagulating ElectrodesGEI · Traditional | 08/19/1982SE |
| K821817 | Pigtail Nasal CathetersFGE · Traditional | 08/10/1982SE |
Questions and answers
When was Pigtail Stents cleared by the FDA?
Pigtail Stents (K821819) received a 510(k) decision of Substantially Equivalent on August 20, 1982, 60 days after the submission was received.
What is the product code of K821819?
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.