Andorate Universal Endoscope Tip Guard
FDA 510(k) clearance K202838 · decided 2021-03-05
Clearance details
- K-number
- K202838
- Device name
- Andorate Universal Endoscope Tip Guard
- Applicant
- Ga Health Company Limited
- Decision
- Substantially Equivalent
- Date received
- 2020-09-25
- Decision date
- 2021-03-05
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- OCU
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hong Kong, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile (K191715) | STERIS Corporation | 2020-01-27 |
| Scope ProTech (K191011) | Meditech Endoscopy, Ltd. | 2019-05-07 |
| SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH (K030684) | Acmi Corporation | 2003-06-03 |
| ENDOBOOT (K951104) | United States Endoscopy Group, Inc. | 1995-04-06 |
| SCOPEJOCKEY (K940780) | Fibertech Instruments, Inc. | 1994-05-10 |
Recalls involving this device
No recalls on record reference this clearance.