KNQ — Dilator, Esophageal Class II
FDA product code KNQ covers "Dilator, Esophageal", a Class II medical device regulated under 21 CFR 876.5365. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KNQ
- Device Class
- Class II
- Regulation Number
- 876.5365
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K122924 | boston scientific | CRE FIXED WIRE BALLON DILATION CATHETER | October 24, 2012 |
| K093236 | ethicon endo-surgery | ETHICON ENDO-SURGERYOPTICAL DILATOR | November 10, 2009 |
| K090183 | cook endoscopy | HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON | September 25, 2009 |
| K082995 | safestitch medical | SMART DILATOR | February 6, 2009 |
| K061937 | cook endoscopy | COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON | December 1, 2006 |
| K061787 | boston scientific | MAXFORCE TTS SINGLE-USE BALLOON DILATOR | September 21, 2006 |
| K060302 | cordis europa, n.v | INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED | April 11, 2006 |
| K043605 | cordis europa, n.v | INSCOPE 3-STAGE BALLOON DILATOR | February 4, 2005 |
| K033936 | c.r. bard | BARD ELIMINATOR PET BALLOON DILATORS | January 14, 2004 |
| K031147 | ethicon endo-surgery | OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR | January 12, 2004 |
| K023907 | cordis | CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BA | December 18, 2002 |
| K002363 | medovations | MEDOVATIONS ESOPHAGEAL DILATOR | November 1, 2000 |
| K993720 | cordis | CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER | January 18, 2000 |
| K983373 | b. braun/mcgaw | IMPACT BALLOON DILATION CATHETER | June 22, 1999 |
| K990935 | pilling weck surgical | JACKSON ESOPHAGEAL DILATOR | May 17, 1999 |
| K974788 | boston scientific | CRE(TM) BALLOON DILATATION CATHETER | March 20, 1998 |
| K971320 | boston scientific | CRE BALLOON DILATATION CATHETER | October 9, 1997 |
| K971615 | tri-med specialties | PATTISON ESOPHAGEAL DILATOR | July 24, 1997 |
| K961438 | boston scientific | BALLON DILATATION CATHETER | July 31, 1996 |
| K952656 | boston scientific | XXL BALLOON DILATATION CATHETER | July 19, 1995 |