Esophageal Balloon Dilator
FDA 510(k) K901424 · Telemed Systems, Inc.
510(k) numberK901424
Submission
- Device name
- Esophageal Balloon Dilator
- Applicant
- Telemed Systems, Inc.
Hudson, MA, US - Received
- March 26, 1990
- Decision date
- June 21, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNQ – Dilator, Esophageal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5365
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KNQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K122924 | Cre Fixed Wire Ballon Dilation CatheterKNQ · Special | Boston Scientific Corp | 10/24/2012SE |
| K093236 | Ethicon Endo-Surgeryoptical DilatorKNQ · Special | Ethicon Endo-Surgery, Inc. | 11/10/2009SE |
| K090183 | Hercules 3 Stage Wire Guided Dilation BalloonKNQ · Special | Cook Endoscopy | 09/25/2009SE |
| K082995 | Smart DilatorKNQ · Traditional | Safestitch Medical | 02/06/2009SE |
| K061937 | Cook Endoscopy Esophageal Dilation BalloonKNQ · Traditional | Cook Endoscopy | 12/01/2006SE |
| K061787 | Maxforce TTS Single-Use Balloon DilatorKNQ · Traditional | Boston Scientific Corp | 09/21/2006SE |
| K060302 | Inscope Precision Balloon Dilator - Wire GuidedKNQ · Traditional | Cordis Europa, N.V. | 04/11/2006SE |
| K043605 | Inscope 3-STAGE Balloon DilatorKNQ · Traditional | Cordis Europa, N.V. | 02/04/2005SE |
| K033936 | Bard Eliminator PET Balloon DilatorsKNQ · Special | C.R. Bard, Inc. | 01/14/2004SE |
| K031147 | Optical DVS (Dual Vector Shearing) Esophageal DilatorKNQ · Traditional | Ethicon Endo-Surgery, Inc. | 01/12/2004SE |
More from Ethicon Endo-Surgery, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K020379 | PPD Balloon Dilatation CatheterKNT · Special | 05/06/2002SE |
| K013737 | Modification to: 3-LUMEN Duralon Occlusion BalloonFGE · Special | 03/01/2002SE |
| K010412 | Flexible Endoscopic ScissorsOCZ · Traditional | 04/02/2001SE |
| K992402 | 5.0 French X 200CM X 35MM Tip TAPER-20MM Cutting Wire, 5.0 French X 200CM X 35MM Tip…KNS · Traditional | 12/22/1999SE |
| K992390 | Hot Biopsy Forceps Feenestrated 230 CM Oval Cup, Hot Biopsy Forceps Serrated 160 CM Oval…KGE · Traditional | 12/22/1999SE |
| K974312 | Reusable Biopsy Forceps Oval Cup, Reusable Biosy Forceps Oval Cup W/Needle, Reusable…KNW · Traditional | 01/21/1998SE |
| K974300 | Telemed Systems Retrieval BasketOCZ · Traditional | 12/19/1997SE |
| K901435 | Gastrointestinal Cytology BrushFDX · Traditional | 07/16/1990SE |
| K901427 | Biliary Stone Retrieval and Occlusion BalloonFGE · Traditional | 06/22/1990SE |
| K901433 | Sure-Flex Anastomotic Balloon DilatorFGE · Traditional | 06/21/1990SE |
Questions and answers
When was Esophageal Balloon Dilator cleared by the FDA?
Esophageal Balloon Dilator (K901424) received a 510(k) decision of Substantially Equivalent on June 21, 1990, 87 days after the submission was received.
What is the product code of K901424?
The FDA product code is KNQ – Dilator, Esophageal, a Class II (moderate risk) device regulated under 21 CFR 876.5365.