The following data is part of a premarket notification filed by Olympus Surgical Technologies America with the FDA for Cleverlock Guidewire Locking Device And Biopsy Cap.
Device ID | K190164 |
510k Number | K190164 |
Device Name: | CleverLock Guidewire Locking Device And Biopsy Cap |
Classification | Endoscope Channel Accessory |
Applicant | Olympus Surgical Technologies America 136 Turnpike Road Southborough, MA 01772 -2104 |
Contact | Mary Anne Patella |
Correspondent | Mary Anne Patella Olympus Surgical Technologies America 136 Turnpike Road Southborough, MA 01772 -2104 |
Product Code | ODC |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-01-31 |
Decision Date | 2019-04-04 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00821925043343 | K190164 | 000 |