Tri-Dils-Triple Olive-Esophageal Dilator
FDA 510(k) K830586 · Keymed, Inc.
510(k) numberK830586
Submission
- Device name
- Tri-Dils-Triple Olive-Esophageal Dilator
- Applicant
- Keymed, Inc.
Mchenry, IL, US - Received
- February 23, 1983
- Decision date
- March 24, 1983
- 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 |
|---|---|---|
| K100803 | Olympus Flushing Pump Ofp Model: OFP-1FEQ · Special | 04/22/2010SE |
| K921179 | Olympus-Keymed Disinfectant Fume Extractor DFE-20FEB · Traditional | 03/29/1993SE |
| K881004 | Olympus-Keymed Endoscopic CO2 Regulator, Model EcrFCX · Traditional | 05/12/1988SE |
| K861821 | Keymed Fiberscope Auto DisinfectorNVE · Traditional | 02/12/1987SE |
| K864801 | The Keymed Hi-Light 250 Light SourceGCT · Traditional | 12/24/1986SE |
| K862000 | Keymed Flexible Esophageal DilatorsKNQ · Traditional | 08/12/1986SE |
| K860528 | The Keymed Fiberscope Sterilization CaseKCT · Traditional | 07/15/1986SE |
| K861147 | UCS-2, Ultrasonic Cleaning SolutionFLG · Traditional | 06/23/1986SE |
| K860704 | The Keymed Sigmoidoscope Disinfection StandNZA · Traditional | 06/17/1986SE |
| K851149 | Key Med Transendoscopic Vascular Detector TVD-1JAF · Traditional | 11/26/1985SE |
Questions and answers
When was Tri-Dils-Triple Olive-Esophageal Dilator cleared by the FDA?
Tri-Dils-Triple Olive-Esophageal Dilator (K830586) received a 510(k) decision of Substantially Equivalent on March 24, 1983, 29 days after the submission was received.
What is the product code of K830586?
The FDA product code is KNQ – Dilator, Esophageal, a Class II (moderate risk) device regulated under 21 CFR 876.5365.