Celestin Dilator
FDA 510(k) K812289 · Inmed Corp.
510(k) numberK812289
Submission
- Device name
- Celestin Dilator
- Applicant
- Inmed Corp.
Mchenry, IL, US - Received
- August 13, 1981
- Decision date
- September 1, 1981
- 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 |
|---|---|---|
| K862672 | Esophageal Stethoscope with ThermistorBZT · Traditional | 10/27/1986SE |
| K853162 | Sterile Nasopharyngeal AirwayBTQ · Traditional | 08/06/1985SE |
| K850335 | Ureteroscopy CatheterKOD · Traditional | 03/12/1985SE |
| K850248 | Disposable Guedel AirwayCAE · Traditional | 03/12/1985SE |
| K850152 | Preconnected Urethral Catheter Tray · Traditional | 03/12/1985SE |
| K844801 | Ultra External CatheterKNX · Traditional | 01/15/1985SE |
| K842301 | Disposable Latex BandageKGX · Traditional | 11/05/1984SE |
| K842866 | Urethral Catheterization TrayKOD · Traditional | 09/10/1984SE |
| K841040 | Fox Post Nasal Balloon CatheterEMX · Traditional | 08/17/1984SE |
| K842865 | Esophageal StethoscopeBZW · Traditional | 08/15/1984SE |
Questions and answers
When was Celestin Dilator cleared by the FDA?
Celestin Dilator (K812289) received a 510(k) decision of Substantially Equivalent on September 1, 1981, 19 days after the submission was received.
What is the product code of K812289?
The FDA product code is KNQ – Dilator, Esophageal, a Class II (moderate risk) device regulated under 21 CFR 876.5365.