Panels › Gastroenterology, Urology › Product code FEQ · Class 2
Pump, Air, Non-Manual, For Endoscope
Regulation 876.1500
0510(k)s in 12 months (21 all time)
1recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in FEQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Endochoice, Inc. | 6 | 0 |
| United States Endoscopy Group, Inc. | 6 | 0 |
| Erbe USA, Inc. | 3 | 0 |
| Keymed (Medical & Industrial Equipment), Ltd. | 2 | 0 |
| Olympus America Inc. | 0 | 2 |
| Olympus Corporation of the Americas | 0 | 2 |
| Byrne Medical, Inc. | 1 | 0 |
| Erbe Medical, LLC | 0 | 1 |
| Keymed, Inc. | 1 | 0 |
| STERIS Corporation | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2026 | Erbe Medical, LLC ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for Oly Open, Classified |
FEQ | K132340 K162152 |
| Oct 25, 2024 | Olympus Corporation of the Americas Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141) Open, Classified |
FEQ | K100899 |
| Oct 8, 2015 | Olympus Corporation of the Americas MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing. Terminated |
FEQ | K100899 |
| Nov 15, 2013 | Olympus America Inc. Olympus Endoscopic Flushing Pump, Model OPF-2.
Facilitates washing of tissues to remove blood, feces and other organic matter during endoscopic procedures. Terminated |
FEQ | K100899 |
| Jan 18, 2012 | Olympus America Inc. Olympus OFP Flushing Pump irrigation tubing
The Olympus OFP Flushing Pump is a peristaltic flushing pump intended for use with Olympus gastrointestinal videoscopes having an auxiliary water inlet as Terminated |
FEQ | K000948 |
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