ENDOBOOT
FDA 510(k) clearance K951104 · decided 1995-04-06
Clearance details
- K-number
- K951104
- Device name
- ENDOBOOT
- Applicant
- United States Endoscopy Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-03-10
- Decision date
- 1995-04-06
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- OCU
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mentor, OH, US
- 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 |
|---|---|---|
| Andorate Universal Endoscope Tip Guard (K202838) | Ga Health Company Limited | 2021-03-05 |
| 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 |
| SCOPEJOCKEY (K940780) | Fibertech Instruments, Inc. | 1994-05-10 |
Recalls involving this device
No recalls on record reference this clearance.