| Device Type ID | 1956 |
| Device Name | Dilator, Esophageal |
| Regulation Description | Esophageal Dilator. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Gastroenterology Devices Branch (GEDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 876.5365 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KNQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 1956 |
| Device | Dilator, Esophageal |
| Product Code | KNQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Esophageal Dilator. |
| CFR Regulation Number | 876.5365 [🔎] |
| Device Problems | |
|---|---|
Balloon | 313 |
Material Rupture | 251 |
Burst Container Or Vessel | 229 |
Use Of Device Problem | 145 |
Hole In Material | 109 |
Crack | 94 |
Leak / Splash | 72 |
Deflation Problem | 66 |
Detachment Of Device Component | 59 |
Catheter | 52 |
Device Subassembly | 46 |
Material Puncture / Hole | 33 |
Material Deformation | 26 |
Improper Or Incorrect Procedure Or Method | 25 |
Break | 24 |
Off-Label Use | 21 |
Material Fragmentation | 19 |
Detachment Of Device Or Device Component | 16 |
Difficult To Remove | 16 |
Tear, Rip Or Hole In Device Packaging | 15 |
Bent | 14 |
Material Separation | 14 |
Tip | 12 |
Adverse Event Without Identified Device Or Use Problem | 11 |
Fluid Leak | 11 |
Delivered As Unsterile Product | 9 |
Contamination / Decontamination Problem | 9 |
Shaft | 8 |
Unsealed Device Packaging | 7 |
Material Twisted / Bent | 6 |
Inflation Problem | 4 |
Torn Material | 4 |
Kinked | 4 |
Device Damaged By Another Device | 3 |
Fracture | 3 |
Device Operates Differently Than Expected | 3 |
Device-Device Incompatibility | 2 |
Entrapment Of Device | 2 |
Volume Accuracy Problem | 2 |
Device Markings / Labelling Problem | 2 |
Insufficient Information | 2 |
Material Perforation | 2 |
Packaging Problem | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Device Damaged Prior To Use | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
Pressure Problem | 1 |
Device Packaging Compromised | 1 |
Material Integrity Problem | 1 |
Guidewire | 1 |
Product Quality Problem | 1 |
Deformation Due To Compressive Stress | 1 |
Device Dislodged Or Dislocated | 1 |
Seal | 1 |
Loss Of Or Failure To Bond | 1 |
| Total Device Problems | 1778 |