KNQ · Dilator, Esophageal
Gastroenterology, Urology · 21 CFR 876.5365 · Class 2
Overview
| Product Code | KNQ |
|---|---|
| Device Name | Dilator, Esophageal |
| Regulation | 21 CFR 876.5365 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Recent Cleared Devices (20 of 40)
Showing 20 most recent of 40 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K122924 | CRE FIXED WIRE BALLON DILATION CATHETER | Boston Scientific Corp | Oct 24, 2012 | SESE |
| K093236 | ETHICON ENDO-SURGERYOPTICAL DILATOR | Ethicon Endo-Surgery, Inc. | Nov 10, 2009 | SESE |
| K090183 | HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON | Cook Endoscopy | Sep 25, 2009 | SESE |
| K082995 | SMART DILATOR | Safestitch Medical | Feb 6, 2009 | SESE |
| K061937 | COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON | Cook Endoscopy | Dec 1, 2006 | SESE |
| K061787 | MAXFORCE TTS SINGLE-USE BALLOON DILATOR | Boston Scientific Corp | Sep 21, 2006 | SESE |
| K060302 | INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED | Cordis Europa, N.V. | Apr 11, 2006 | SESE |
| K043605 | INSCOPE 3-STAGE BALLOON DILATOR | Cordis Europa, N.V. | Feb 4, 2005 | SESE |
| K033936 | BARD ELIMINATOR PET BALLOON DILATORS | C.R. Bard, Inc. | Jan 14, 2004 | SESE |
| K031147 | OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR | Ethicon Endo-Surgery, Inc. | Jan 12, 2004 | SESE |
| K023907 | CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER | Cordis Corp. | Dec 18, 2002 | SESE |
| K002363 | MEDOVATIONS ESOPHAGEAL DILATOR | Medovations, Inc. | Nov 1, 2000 | SESE |
| K993720 | CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER | Cordis Corp. | Jan 18, 2000 | SESE |
| K983373 | IMPACT BALLOON DILATION CATHETER | B. Braun/Mcgaw | Jun 22, 1999 | SESE |
| K990935 | JACKSON ESOPHAGEAL DILATOR | Pilling Weck Surgical | May 17, 1999 | SESE |
| K974788 | CRE(TM) BALLOON DILATATION CATHETER | Boston Scientific Corp | Mar 20, 1998 | SESE |
| K971320 | CRE BALLOON DILATATION CATHETER | Boston Scientific Corp | Oct 9, 1997 | SESE |
| K971615 | PATTISON ESOPHAGEAL DILATOR | Tri-Med Specialties, Inc. | Jul 24, 1997 | SESE |
| K961438 | BALLON DILATATION CATHETER | Boston Scientific Corp | Jul 31, 1996 | SESE |
| K952656 | XXL BALLOON DILATATION CATHETER | Boston Scientific Corp | Jul 19, 1995 | SESE |
Top Applicants
- Boston Scientific Corp — 7 clearances
- Medovations, Inc. — 3 clearances
- Wilson-Cook Medical, Inc. — 3 clearances
- Cook Endoscopy — 2 clearances
- Cordis Corp. — 2 clearances
