510(k) K152531 ยท EOB Nasopharyngoscope (Flexible Or Rigid)
InstaClear Lens Cleaner
| Applicant | Gyrus Acmi, Inc., Southborough MA, US |
| Decision | Substantially Equivalent, Jan 15, 2016 |
| Received | Sep 3, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152531
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2024 | Olympus Corporation of the Americas InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remove it from the nasal Open, Classified |
EOB | None listed |
| Mar 22, 2024 | Olympus Corporation of the Americas InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery.
Model Number:
LCS1500UNOL
LCS1800UNST
LCS4K00UNOL
LCS1530BTOL
LCS1830BTST
LCS4K30BTO Open, Classified |
EOB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.