510(k) K940780
- Device
- SCOPEJOCKEY
- Applicant
- FIBERTECH INSTRUMENTS, INC.
- 510(k) number
- K940780
- Product code
- OCU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-05-10
- Date received
- 1994-02-22
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- FRANK MAJEROWICZ
- Address
- 5020 Campbell Blvd., Suite K Baltimore MD US 21236 21236
FDA Registration Numbers#
- 1528319
- 3011346938
- 2246552
- 3008058134
- 3014749926
- 1047843
- 3011050570
- 1519132
- 3003790304
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K191715 | Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile | STERIS Corporation | 2020-01-27 |
| 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 |
Legacy Summary#
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FDA Review#
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