Panels › Ear, Nose, Throat › Product code EOB · Class 2
Nasopharyngoscope (Flexible Or Rigid)
Regulation 874.4760
5510(k)s in 12 months (163 all time)
1recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in EOB
| Company | 510(k)s | Recalls |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 28 | 0 |
| Vision-Sciences, Inc. | 15 | 2 |
| Olympus Medical Systems Corp. | 8 | 0 |
| Acclarent, Inc. | 4 | 0 |
| Pentax of America, Inc. | 4 | 0 |
| 3nt Medical , Ltd. | 3 | 0 |
| Ambu A/S | 3 | 0 |
| Karl Storz Endoscopy | 1 | 2 |
| Olympus America, Inc. | 3 | 0 |
| Olympus Corporation of the Americas | 0 | 3 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2026 | Karl Storz Endoscopy HOPKINS Telescope 30, 4mm REF 10005BA
UDI-DI code: 04048551045121
KARL STORZ HOPKINS and HOPKINS II telescopes are to be used for visualization of the surgical site during diagnostic and therapeutic Open, Classified |
EOB | K945788 |
| 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 | K152531 |
| 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 | K152531 |
| Jan 9, 2024 | Shirakawa Olympus Co., Ltd. Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE Open, Classified |
EOB | K221660 |
| Apr 1, 2022 | Karl Storz Endoscopy 11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018) Open, Classified |
EOB | K171402 |
| May 5, 2020 | Olympus Corporation of the Americas ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen. Terminated |
EOB | K181240 |
| Jun 28, 2016 | Pentax Medical Company Naso-Pharyngo-Laryngoscope
Intended to provide optical visualization of, therapeutic access to, the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: E Terminated |
EOB | K921707 |
| Jan 29, 2012 | Vision-Sciences, Inc. Product is a lithium ion battery sold as both a stand-alone accessory, and as part of endoscopy system sets. Stand alone labeling: Vision Sciences Rechargeable Lithium Ion Batteries, Replacement (2) [ Terminated |
EOB | K050972 K100125 |
| Jan 29, 2012 | Vision-Sciences, Inc. Product is a lithium ion battery charger sold as both a stand-alone accessory, and as part of endoscopy system sets. --- Stand alone labeling: Vision Sciences Battery Charger, Lithium Ion [REF] 07-305 Terminated |
EOB | K050972 K100125 |
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