OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2— 510(k) K100899
Substantially EquivalentKeymed (Medical & Industrial Equipment), Ltd.
FDA 510(k) clearance K100899 for OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2, Substantially Equivalent on 2010-09-13. Applicant: Keymed (Medical & Industrial Equipment), Ltd.. Device class: 2.
Clearance details
- Applicant
- Keymed (Medical & Industrial Equipment), Ltd.
- Product code
- Code FEQ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code FEQ
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- K182258 — AquaShield System CO2; AquaShield System CO2 - PENTAX; AquaShield System CO2 - Fujifilm
- K173650 — AquaShield System CO2- Fujifilm
- K163424 — AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON
More clearances from Keymed (Medical & Industrial Equipment), Ltd.
view allAdverse events under product code FEQ
product code FEQ- Malfunction
- 1,135
- Total
- 1,135
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K100899
K-number listed on FDA's recall record- Z-0229-2025 — Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
- Z-0113-2016 — 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.
- Z-0329-2014 — Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feces and other organic matter during endoscopic procedures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100899.
Data sourced from openFDA. This site is unofficial and independent of the FDA.