Bioteq Pigtail Drainage Catheter Set (One Step Type) with or Without Safety String Lock
FDA 510(k) K033862 · Bioteque Corp.
510(k) numberK033862
Submission
- Device name
- Bioteq Pigtail Drainage Catheter Set (One Step Type) with or Without Safety String Lock
- Applicant
- Bioteque Corp.
Taipei, TW - Received
- December 12, 2003
- Decision date
- February 14, 2005
- 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 |
|---|---|---|
| K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-GFGE · Traditional | 12/22/2025SE |
| K210419 | BIOTEQ Drainage Catheter BT-PDS-seriesFGE · Traditional | 04/13/2022SE |
| K200103 | BIOTEQ Drainage Catheter Set (One Step Type)FGE · Traditional | 10/09/2020SE |
| K150932 | Sheath IntroducerDRE · Traditional | 07/22/2016SE |
| K102633 | Bioteq Angiographic CatheterDQO · Traditional | 09/09/2011SE |
| K033210 | Bioteq Double Pigtail Ureteral Stent SetFAD · Traditional | 12/30/2004SE |
| K032292 | Bioteque A.V. Fistula Needle Set with Safety FlexFOZ · Traditional | 03/22/2004SE |
| K013634 | Bioteque 3 in 1 Hemodialysis Blood Tubing PackFJK · Traditional | 07/09/2002SESK |
| K012526 | Bioteque Scalp Vein SetFPA · Traditional | 09/14/2001SE |
| K002449 | Bioteq I.V. (Intravenous) SetFPA · Traditional | 12/22/2000SE |
Questions and answers
When was Bioteq Pigtail Drainage Catheter Set (One Step Type) with or Without Safety String Lock cleared by the FDA?
Bioteq Pigtail Drainage Catheter Set (One Step Type) with or Without Safety String Lock (K033862) received a 510(k) decision of Substantially Equivalent on February 14, 2005, 430 days after the submission was received.
What is the product code of K033862?
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.