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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08714729339359 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 10653405050780 | NA | Conmed Corporation | 2016-09-24 |
| 10653405050773 | CONMED | Conmed Corporation | 2016-09-24 |
| 10653405050766 | CONMED | Conmed Corporation | 2016-09-24 |
| 10653405050759 | NA | Conmed Corporation | 2016-09-24 |
| 10653405050742 | CONMED | Conmed Corporation | 2016-09-24 |
| 10653405050735 | CONMED | Conmed Corporation | 2016-09-24 |
| 10653405050728 | CONMED | Conmed Corporation | 2016-09-24 |
| 10653405050711 | CONMED | Conmed Corporation | 2016-09-24 |
| 10653405050704 | NA | Conmed Corporation | 2016-09-24 |
| 08714729339427 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729339403 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729339397 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729339380 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729339373 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729163039 | XXL™ Esophageal | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729339335 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729339328 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729202011 | CRE Fixed Wire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729195993 | CRE Fixed Wire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729195986 | CRE Fixed Wire | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729163190 | XXL™ Esophageal | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729163176 | XXL™ Esophageal | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729163169 | XXL™ Esophageal | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729163145 | XXL™ Esophageal | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729163121 | XXL™ Esophageal | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729163114 | XXL™ Esophageal | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729163084 | XXL™ Esophageal | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729163060 | XXL™ Esophageal | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729163053 | XXL™ Esophageal | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |