Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart F — Therapeutic Devices](/submissions/GU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 876.5365](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5365) → KNQ — Dilator, Esophageal # KNQ · Dilator, Esophageal _Gastroenterology, Urology · 21 CFR 876.5365 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ ## Overview - **Product Code:** KNQ - **Device Name:** Dilator, Esophageal - **Regulation:** [21 CFR 876.5365](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5365) - **Device Class:** 2 - **Review Panel:** [Gastroenterology, Urology](/submissions/GU) ## 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](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ/K122924.md) | CRE FIXED WIRE BALLON DILATION CATHETER | Boston Scientific Corp | Oct 24, 2012 | SESE | | [K093236](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ/K093236.md) | ETHICON ENDO-SURGERYOPTICAL DILATOR | Ethicon Endo-Surgery, Inc. | Nov 10, 2009 | SESE | | [K090183](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ/K090183.md) | HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON | Cook Endoscopy | Sep 25, 2009 | SESE | | [K082995](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ/K082995.md) | SMART DILATOR | Safestitch Medical | Feb 6, 2009 | SESE | | [K061937](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ/K061937.md) | COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON | Cook Endoscopy | Dec 1, 2006 | SESE | | [K061787](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ/K061787.md) | MAXFORCE TTS SINGLE-USE BALLOON DILATOR | Boston Scientific Corp | Sep 21, 2006 | SESE | | [K060302](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ/K060302.md) | INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED | Cordis Europa, N.V. | Apr 11, 2006 | SESE | | [K043605](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ/K043605.md) | INSCOPE 3-STAGE BALLOON DILATOR | Cordis Europa, N.V. | Feb 4, 2005 | SESE | | [K033936](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ/K033936.md) | BARD ELIMINATOR PET BALLOON DILATORS | C.R. Bard, Inc. | Jan 14, 2004 | SESE | | [K031147](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ/K031147.md) | OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR | Ethicon Endo-Surgery, Inc. | Jan 12, 2004 | SESE | | [K023907](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ/K023907.md) | CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER | Cordis Corp. | Dec 18, 2002 | SESE | | [K002363](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ/K002363.md) | MEDOVATIONS ESOPHAGEAL DILATOR | Medovations, Inc. | Nov 1, 2000 | SESE | | [K993720](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ/K993720.md) | CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER | Cordis Corp. | Jan 18, 2000 | SESE | | [K983373](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ/K983373.md) | IMPACT BALLOON DILATION CATHETER | B. Braun/Mcgaw | Jun 22, 1999 | SESE | | [K990935](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ/K990935.md) | JACKSON ESOPHAGEAL DILATOR | Pilling Weck Surgical | May 17, 1999 | SESE | | [K974788](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ/K974788.md) | CRE(TM) BALLOON DILATATION CATHETER | Boston Scientific Corp | Mar 20, 1998 | SESE | | [K971320](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ/K971320.md) | CRE BALLOON DILATATION CATHETER | Boston Scientific Corp | Oct 9, 1997 | SESE | | [K971615](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ/K971615.md) | PATTISON ESOPHAGEAL DILATOR | Tri-Med Specialties, Inc. | Jul 24, 1997 | SESE | | [K961438](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ/K961438.md) | BALLON DILATATION CATHETER | Boston Scientific Corp | Jul 31, 1996 | SESE | | [K952656](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ/K952656.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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