Ethicon Endo-Surgeryoptical Dilator
FDA 510(k) K093236 · Ethicon Endo-Surgery, Inc.
510(k) numberK093236
Submission
- Device name
- Ethicon Endo-Surgeryoptical Dilator
- Applicant
- Ethicon Endo-Surgery, Inc.
Cincinnati, OH, US - Received
- October 15, 2009
- Decision date
- November 10, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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
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|---|---|---|---|
| K122924 | Cre Fixed Wire Ballon Dilation CatheterKNQ · Special | Boston Scientific Corp | 10/24/2012SE |
| 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 |
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Questions and answers
When was Ethicon Endo-Surgeryoptical Dilator cleared by the FDA?
Ethicon Endo-Surgeryoptical Dilator (K093236) received a 510(k) decision of Substantially Equivalent on November 10, 2009, 26 days after the submission was received.
What is the product code of K093236?
The FDA product code is KNQ – Dilator, Esophageal, a Class II (moderate risk) device regulated under 21 CFR 876.5365.