FDA Product Code
FDA Product Code KNQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5365
510(k) Clearances — 40 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K122924 | CRE FIXED WIRE BALLON DILATION CATHETER | Boston Scientific Corp | 2012-10-24 | Special | PDF ↗ |
| K093236 | ETHICON ENDO-SURGERYOPTICAL DILATOR | Ethicon Endo-Surgery, Inc. | 2009-11-10 | Special | PDF ↗ |
| K090183 | HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON | Cook Endoscopy | 2009-09-25 | Special | PDF ↗ |
| K082995 | SMART DILATOR | Safestitch Medical | 2009-02-06 | Traditional | PDF ↗ |
| K061937 | COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON | Cook Endoscopy | 2006-12-01 | Traditional | PDF ↗ |
| K061787 | MAXFORCE TTS SINGLE-USE BALLOON DILATOR | Boston Scientific Corp | 2006-09-21 | Traditional | PDF ↗ |
| K060302 | INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED | Cordis Europa, N.V. | 2006-04-11 | Traditional | PDF ↗ |
| K043605 | INSCOPE 3-STAGE BALLOON DILATOR | Cordis Europa, N.V. | 2005-02-04 | Traditional | PDF ↗ |
| K033936 | BARD ELIMINATOR PET BALLOON DILATORS | C.R. Bard, Inc. | 2004-01-14 | Special | PDF ↗ |
| K031147 | OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR | Ethicon Endo-Surgery, Inc. | 2004-01-12 | Traditional | PDF ↗ |
| K023907 | CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER | Cordis Corp. | 2002-12-18 | Special | PDF ↗ |
| K002363 | MEDOVATIONS ESOPHAGEAL DILATOR | Medovations, Inc. | 2000-11-01 | Traditional | PDF ↗ |
| K993720 | CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER | Cordis Corp. | 2000-01-18 | Traditional | PDF ↗ |
| K983373 | IMPACT BALLOON DILATION CATHETER | B. Braun/Mcgaw | 1999-06-22 | Traditional | PDF ↗ |
| K990935 | JACKSON ESOPHAGEAL DILATOR | Pilling Weck Surgical | 1999-05-17 | Traditional | PDF ↗ |
| K974788 | CRE(TM) BALLOON DILATATION CATHETER | Boston Scientific Corp | 1998-03-20 | Traditional | PDF ↗ |
| K971320 | CRE BALLOON DILATATION CATHETER | Boston Scientific Corp | 1997-10-09 | Traditional | PDF ↗ |
| K971615 | PATTISON ESOPHAGEAL DILATOR | Tri-Med Specialties, Inc. | 1997-07-24 | Traditional | PDF ↗ |
| K961438 | BALLON DILATATION CATHETER | Boston Scientific Corp | 1996-07-31 | Traditional | PDF ↗ |
| K952656 | XXL BALLOON DILATATION CATHETER | Boston Scientific Corp | 1995-07-19 | Traditional | PDF ↗ |
| K924646 | OVER THE GUIDEWIRE DILATATION SYSTEM | Medovations, Inc. | 1994-12-05 | Traditional | PDF ↗ |
| K933845 | WILSON-COOK BALLOON INFLATION DEVICE | Wilson-Cook Medical, Inc. | 1994-11-29 | Traditional | PDF ↗ |
| K934697 | MICROVASIVE MAXFORCE | Boston Scientific Corp | 1994-05-16 | Traditional | PDF ↗ |
| K932015 | TRI-MED INFLATABLE ESOPHAGEAL DILATOR | Tri-Med Specialties, Inc. | 1994-02-03 | Traditional | PDF ↗ |
| K933992 | OLYMPUS SCLEROTHERAPY BALLOON | Olympus Corp. | 1993-12-21 | Traditional | PDF ↗ |
| K926038 | FLEX-TECH BALLOON DILATOR | Cape Tech Medical Products | 1993-10-25 | Traditional | PDF ↗ |
| K900924 | WILSON-COOK BALLOON DILATION CATHETERS | Wilson-Cook Medical, Inc. | 1990-12-21 | Traditional | PDF ↗ |
| K901424 | ESOPHAGEAL BALLOON DILATOR | Telemed Systems, Inc. | 1990-06-21 | Traditional | PDF ↗ |
| K884715 | ACHELASIA BALLOON DIALATOR | Primrose Medical, Inc. | 1989-09-29 | Traditional | PDF ↗ |
| K884712 | ESOPHAGEAL AND PYLORIC BALLOON DIALATORS | Primrose Medical, Inc. | 1989-09-08 | Traditional | PDF ↗ |
| K883526 | PORGES STEPPED NEOPLEX DILATOR | Porges Corp. | 1988-10-28 | Traditional | PDF ↗ |
| K881478 | MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS | Keymed (Medical & Industrial Equipment), Ltd. | 1988-09-14 | Traditional | PDF ↗ |
| K862000 | KEYMED FLEXIBLE ESOPHAGEAL DILATORS | Keymed, Inc. | 1986-08-12 | Traditional | PDF ↗ |
| K853274 | AMERICAN DILATATION SYSTEM | American Endoscopy, Inc. | 1985-10-17 | Traditional | PDF ↗ |
| K851955 | SAVARY-GILLIARD DILATOR | Wilson-Cook Medical, Inc. | 1985-07-25 | Traditional | PDF ↗ |
| K841310 | GASTROINTESTINAL DILATOR | Thomas J. Fogarty, M.D. | 1984-07-31 | Traditional | PDF ↗ |
| K834451 | COAXIAL BALLOON GASTROESOPHAGEAL DILA | Thomas J. Fogarty, M.D. | 1984-02-04 | Traditional | PDF ↗ |
| K830991 | ESOPHAGEAL BOUGIES | Medovations, Inc. | 1983-06-02 | Traditional | PDF ↗ |
| K830586 | TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR | Keymed, Inc. | 1983-03-24 | Traditional | PDF ↗ |
| K812289 | CELESTIN DILATOR | Inmed Corp. | 1981-09-01 | Traditional | PDF ↗ |
Product code KNQ · Class II · Gastroenterology, Urology. Data: openFDA.