Dilator, Esophageal
FDA product code KNQ · Class II (moderate risk) · 21 CFR 876.5365 · Gastroenterology, Urology
40510(k) clearances
0PMA approvals
19recalls
Manufacturers
- Boston Scientific Corporation 7
- Medovations, Inc. 3
- Wilson-Cook Medical, Inc. 3
- Keymed, Inc. 2
- Cook Endoscopy 2
- Cordis Europa, N.V. 2
- Ethicon Endo-Surgery, Inc. 2
- Cordis Corp. 2
- Tri-Med Specialties, Inc. 2
- Primrose Medical, Inc. 2
- Thomas J. Fogarty, M.D. 2
- Telemed Systems, Inc. 1
- Cape Tech Medical Products 1
- Olympus Corp. 1
- Porges Corp. 1
- Pilling Weck Surgical 1
- B. Braun/Mcgaw 1
- Keymed (Medical & Industrial Equipment), Ltd. 1
- American Endoscopy, Inc. 1
- Safestitch Medical 1
510(k) clearances
| 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 |
| K023907 | Cordis Maxi LD Large Diameter Balloon Dilatation Catheter, Cordis Maxi LD Pta Balloon…KNQ · Special | Cordis Corp. | 12/18/2002SE |
| K002363 | Medovations Esophageal DilatorKNQ · Traditional | Medovations, Inc. | 11/01/2000SE |
| K993720 | Cordis Maxi LD Large Diameter Balloon Dilatation CatheterKNQ · Traditional | Cordis Corp. | 01/18/2000SE |
| K983373 | Impact Balloon Dilation CatheterKNQ · Traditional | B. Braun/Mcgaw | 06/22/1999SE |
| K990935 | Jackson Esophageal DilatorKNQ · Traditional | Pilling Weck Surgical | 05/17/1999SE |
| K974788 | Cre(Tm) Balloon Dilatation CatheterKNQ · Traditional | Boston Scientific Corp | 03/20/1998SE |
| K971320 | Cre Balloon Dilatation CatheterKNQ · Traditional | Boston Scientific Corp | 10/09/1997SE |
| K971615 | Pattison Esophageal DilatorKNQ · Traditional | Tri-Med Specialties, Inc. | 07/24/1997SE |
| K961438 | Ballon Dilatation CatheterKNQ · Traditional | Boston Scientific Corp | 07/31/1996SE |
| K952656 | XXL Balloon Dilatation CatheterKNQ · Traditional | Boston Scientific Corp | 07/19/1995SE |
| K924646 | Over the Guidewire Dilatation SystemKNQ · Traditional | Medovations, Inc. | 12/05/1994SE |
| K933845 | Wilson-Cook Balloon Inflation DeviceKNQ · Traditional | Wilson-Cook Medical, Inc. | 11/29/1994SE |
| K934697 | Microvasive MaxforceKNQ · Traditional | Boston Scientific Corp | 05/16/1994SE |
| K932015 | Tri-Med Inflatable Esophageal DilatorKNQ · Traditional | Tri-Med Specialties, Inc. | 02/03/1994SE |
| K933992 | Olympus Sclerotherapy BalloonKNQ · Traditional | Olympus Corp. | 12/21/1993SE |
| K926038 | Flex-Tech Balloon DilatorKNQ · Traditional | Cape Tech Medical Products | 10/25/1993SE |
| K900924 | Wilson-Cook Balloon Dilation CathetersKNQ · Traditional | Wilson-Cook Medical, Inc. | 12/21/1990SE |
| K901424 | Esophageal Balloon DilatorKNQ · Traditional | Telemed Systems, Inc. | 06/21/1990SE |
| K884715 | Achelasia Balloon DialatorKNQ · Traditional | Primrose Medical, Inc. | 09/29/1989SE |
| K884712 | Esophageal and Pyloric Balloon DialatorsKNQ · Traditional | Primrose Medical, Inc. | 09/08/1989SE |
| K883526 | Porges Stepped Neoplex DilatorKNQ · Traditional | Porges Corp. | 10/28/1988SE |
| K881478 | Modified Keymed Flexible Esophageal DilatorsKNQ · Traditional | Keymed (Medical & Industrial Equipment), Ltd. | 09/14/1988SE |
| K862000 | Keymed Flexible Esophageal DilatorsKNQ · Traditional | Keymed, Inc. | 08/12/1986SE |
| K853274 | American Dilatation SystemKNQ · Traditional | American Endoscopy, Inc. | 10/17/1985SE |
| K851955 | Savary-Gilliard DilatorKNQ · Traditional | Wilson-Cook Medical, Inc. | 07/25/1985SE |
| K841310 | Gastrointestinal DilatorKNQ · Traditional | Thomas J. Fogarty, M.D. | 07/31/1984SE |
| K834451 | Coaxial Balloon Gastroesophageal DilaKNQ · Traditional | Thomas J. Fogarty, M.D. | 02/04/1984SE |
| K830991 | Esophageal BougiesKNQ · Traditional | Medovations, Inc. | 06/02/1983SE |
| K830586 | Tri-Dils-Triple Olive-Esophageal DilatorKNQ · Traditional | Keymed, Inc. | 03/24/1983SE |
| K812289 | Celestin DilatorKNQ · Traditional | Inmed Corp. | 09/01/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1941-2026 Class II | Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF…The catheter inflation tag attached to the device may contain an incorrect part number with incorrect… | Diversatek Healthcare | 03/18/2026Open, Classified |
| Z-1940-2026 Class II | Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF…The catheter inflation tag attached to the device may contain an incorrect part number with incorrect… | Diversatek Healthcare | 03/18/2026Open, Classified |
| Z-1939-2026 Class II | Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF…The catheter inflation tag attached to the device may contain an incorrect part number with incorrect… | Diversatek Healthcare | 03/18/2026Open, Classified |
| Z-1938-2026 Class II | Diversatek Healthcare Viper 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08The catheter inflation tag attached to the device may contain an incorrect part number with incorrect… | Diversatek Healthcare | 03/18/2026Open, Classified |
| Z-1671-2013 Class III | RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510…Product labeled with incorrect expiration date. | Boston Scientific Corporation | 05/28/2013Terminated |
| Z-0949-2007 | ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 20mm (60…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… | Conmed Endoscopic Technologies, Inc. | 04/16/2007Terminated |
| Z-0948-2007 | ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 18mm (54…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… | Conmed Endoscopic Technologies, Inc. | 04/16/2007Terminated |
| Z-0947-2007 | ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 15mm (45…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… | Conmed Endoscopic Technologies, Inc. | 04/16/2007Terminated |
| Z-0946-2007 | ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 12mm (36…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… | Conmed Endoscopic Technologies, Inc. | 04/16/2007Terminated |
| Z-0945-2007 | ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 10mm (30…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… | Conmed Endoscopic Technologies, Inc. | 04/16/2007Terminated |
| Z-0944-2007 | ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 8mm (24…Complaints received regarding PET Balloon Dilators for a variety of labeling errors, including: incorrect… | Conmed Endoscopic Technologies, Inc. | 04/16/2007Terminated |
| Z-0943-2007 | ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 6mm (18…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… | Conmed Endoscopic Technologies, Inc. | 04/16/2007Terminated |
| Z-0942-2007 | ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 20mm (60 Fr)…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… | Conmed Endoscopic Technologies, Inc. | 04/16/2007Terminated |
| Z-0941-2007 | ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 18mm (54 Fr)…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… | Conmed Endoscopic Technologies, Inc. | 04/16/2007Terminated |
| Z-0940-2007 | ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 15mm (45 Fr)…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… | Conmed Endoscopic Technologies, Inc. | 04/16/2007Terminated |
| Z-0939-2007 | ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 12mm (36 Fr)…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… | Conmed Endoscopic Technologies, Inc. | 04/16/2007Terminated |
| Z-0938-2007 | ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 10mm (30 Fr)…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… | Conmed Endoscopic Technologies, Inc. | 04/16/2007Terminated |
| Z-0937-2007 | ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 8mm (24 Fr)…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… | Conmed Endoscopic Technologies, Inc. | 04/16/2007Terminated |
| Z-0520-2007 | Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900…The graphic label is incorrect, it lists 6mm/ 18FR. The product label is correct, it lists 10mm/ 30FR. | Cook Endoscopy | 01/24/2007Terminated |