510(k) K191715
- Device
- Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile
- Applicant
- STERIS Corporation
- 510(k) number
- K191715
- Product code
- OCU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-01-27
- Date received
- 2019-06-26
- Regulation
- 876.1500
- Classification name
- Endoscopic Storage Cover
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jennifer Nalepka
- Address
- 5976 Heisley Rd. Mentor OH US 44060 44060
FDA Registration Numbers#
- 1528319
- 3011346938
- 2246552
- 3008058134
- 3014749926
- 1047843
- 3011050570
- 1519132
- 3003790304
Source Documents#
Other 510(k) Records For Product Code OCU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K202838 | Andorate Universal Endoscope Tip Guard | Ga Health Company Limited | 2021-03-05 |
| K191011 | Scope ProTech | Meditech Endoscopy, Ltd. | 2019-05-07 |
| K030684 | SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH | Acmi Corporation | 2003-06-03 |
| K951104 | ENDOBOOT | United States Endoscopy Group, Inc. | 1995-04-06 |
| K940780 | SCOPEJOCKEY | Fibertech Instruments, Inc. | 1994-05-10 |
Legacy Summary#
summary
FDA Review#
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