Product code KNQ
- Device name
- Dilator, Esophageal
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5365
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K122924 | CRE FIXED WIRE BALLON DILATION CATHETER | Boston Scientific Corp | 2012-10-24 |
| K093236 | ETHICON ENDO-SURGERYOPTICAL DILATOR | Ethicon Endo-Surgery, Inc. | 2009-11-10 |
| K090183 | HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON | Cook Endoscopy | 2009-09-25 |
| K082995 | SMART DILATOR | Safestitch Medical | 2009-02-06 |
| K061937 | COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON | Cook Endoscopy | 2006-12-01 |
| K061787 | MAXFORCE TTS SINGLE-USE BALLOON DILATOR | Boston Scientific Corp | 2006-09-21 |
| K060302 | INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED | Cordis Europa, N.V. | 2006-04-11 |
| K043605 | INSCOPE 3-STAGE BALLOON DILATOR | Cordis Europa, N.V. | 2005-02-04 |
| K033936 | BARD ELIMINATOR PET BALLOON DILATORS | C.R. Bard, Inc. | 2004-01-14 |
| K031147 | OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR | Ethicon Endo-Surgery, Inc. | 2004-01-12 |
| K023907 | CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER | Cordis Corp. | 2002-12-18 |
| K002363 | MEDOVATIONS ESOPHAGEAL DILATOR | Medovations, Inc. | 2000-11-01 |
| K993720 | CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER | Cordis Corp. | 2000-01-18 |
| K983373 | IMPACT BALLOON DILATION CATHETER | B. Braun/Mcgaw | 1999-06-22 |
| K990935 | JACKSON ESOPHAGEAL DILATOR | Pilling Weck Surgical | 1999-05-17 |
| K974788 | CRE(TM) BALLOON DILATATION CATHETER | Boston Scientific Corp | 1998-03-20 |
| K971320 | CRE BALLOON DILATATION CATHETER | Boston Scientific Corp | 1997-10-09 |
| K971615 | PATTISON ESOPHAGEAL DILATOR | Tri-Med Specialties, Inc. | 1997-07-24 |
| K961438 | BALLON DILATATION CATHETER | Boston Scientific Corp | 1996-07-31 |
| K952656 | XXL BALLOON DILATATION CATHETER | Boston Scientific Corp | 1995-07-19 |
| K924646 | OVER THE GUIDEWIRE DILATATION SYSTEM | Medovations, Inc. | 1994-12-05 |
| K933845 | WILSON-COOK BALLOON INFLATION DEVICE | Wilson-Cook Medical, Inc. | 1994-11-29 |
| K934697 | MICROVASIVE MAXFORCE | Boston Scientific Corp | 1994-05-16 |
| K932015 | TRI-MED INFLATABLE ESOPHAGEAL DILATOR | Tri-Med Specialties, Inc. | 1994-02-03 |
| K933992 | OLYMPUS SCLEROTHERAPY BALLOON | Olympus Corp. | 1993-12-21 |
| K926038 | FLEX-TECH BALLOON DILATOR | Cape Tech Medical Products | 1993-10-25 |
| K900924 | WILSON-COOK BALLOON DILATION CATHETERS | Wilson-Cook Medical, Inc. | 1990-12-21 |
| K901424 | ESOPHAGEAL BALLOON DILATOR | Telemed Systems, Inc. | 1990-06-21 |
| K884715 | ACHELASIA BALLOON DIALATOR | Primrose Medical, Inc. | 1989-09-29 |
| K884712 | ESOPHAGEAL AND PYLORIC BALLOON DIALATORS | Primrose Medical, Inc. | 1989-09-08 |
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| 06959664926765 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664929100 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664929070 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664929032 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664929001 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664928974 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664928943 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664927496 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664927465 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664927434 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664927403 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664927120 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664927090 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664927069 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664927038 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664925584 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664926734 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664926703 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664926673 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664926406 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664926376 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664926345 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664926314 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664926048 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664926017 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664925980 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664925959 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |
| 06959664925614 | NA | Hangzhou AGS MedTech Co., Ltd. | 2026-04-15 |