JESBERG ESOPHAGOSCOPES W/AUSTINETIC S S
FDA 510(k) clearance K760652 · decided 1976-12-16
Clearance details
- K-number
- K760652
- Device name
- JESBERG ESOPHAGOSCOPES W/AUSTINETIC S S
- Applicant
- Pilling Co.
- Decision
- Substantially Equivalent
- Date received
- 1976-09-15
- Decision date
- 1976-12-16
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- EOX
- Device class
- 2
- Regulation number
- 874.4710
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| EsoCheck Cell Collection Device (K210137) | Lucid Diagnostics, Inc. | 2021-02-18 |
| CMOS Video Esophagoscope SSU (K192523) | Karl Storz SE & CO. KG | 2020-01-24 |
| EsoCheck CCD Cell Collection Device (K183262) | Lucid Diagnostics, Inc. | 2019-06-21 |
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| PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor (K181292) | Cogentix Medical, Inc. | 2018-11-15 |
| Cytosponge Cell Collection Device (K181020) | Covidien, LLC | 2018-08-16 |
| Cytosponge Cell Collection Device (K152794) | Covidien, LLC | 2016-04-12 |
Recalls involving this device
No recalls on record reference this clearance.