Olympus Flushing Pump Ofp Model: OFP-1
FDA 510(k) K100803 · Keymed, Inc.
510(k) numberK100803
Submission
- Device name
- Olympus Flushing Pump Ofp Model: OFP-1
- Applicant
- Keymed, Inc.
San Diego, CA, US - Received
- March 22, 2010
- Decision date
- April 22, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FEQ – Pump, Air, Non-Manual, For Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FEQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220395 | EndoGator Endoscopy Irrigation TubingFEQ · Special | STERIS Corporation | 03/11/2022SE |
| K191559 | AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILMFEQ · Special | United States Endoscopy Group, Inc. | 08/01/2019SE |
| K182258 | AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - FujifilmFEQ · Special | United States Endoscopy Group, Inc. | 09/21/2018SE |
| K173650 | AquaShield System CO2- FujifilmFEQ · Special | United States Endoscopy Group, Inc. | 01/05/2018SE |
| K163424 | AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 -…FEQ · Special | United State Endoscopy Group, Inc. | 01/04/2017SE |
| K162152 | Erbes CO2 Tubing/Cap SetsFEQ · Special | Erbe USA, Inc. | 08/31/2016SE |
| K161482 | EndoChoice Water Bottle Cap Irrigation SystemFEQ · Special | Endochoice, Inc. | 06/27/2016SE |
| K153588 | EndoChoice Water Bottle Cap SystemFEQ · Special | Endochoice, Inc. | 02/24/2016SE |
| K153362 | AquaShield system CO2, AquaShield system-PENTAXFEQ · Special | United States Endoscopy Group, Inc. | 12/16/2015SE |
| K142155 | Endochoice Water Bottle Cap SystemFEQ · Traditional | Endochoice, Inc. | 01/20/2015SE |
More from Endochoice, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K921179 | Olympus-Keymed Disinfectant Fume Extractor DFE-20FEB · Traditional | 03/29/1993SE |
| K881004 | Olympus-Keymed Endoscopic CO2 Regulator, Model EcrFCX · Traditional | 05/12/1988SE |
| K861821 | Keymed Fiberscope Auto DisinfectorNVE · Traditional | 02/12/1987SE |
| K864801 | The Keymed Hi-Light 250 Light SourceGCT · Traditional | 12/24/1986SE |
| K862000 | Keymed Flexible Esophageal DilatorsKNQ · Traditional | 08/12/1986SE |
| K860528 | The Keymed Fiberscope Sterilization CaseKCT · Traditional | 07/15/1986SE |
| K861147 | UCS-2, Ultrasonic Cleaning SolutionFLG · Traditional | 06/23/1986SE |
| K860704 | The Keymed Sigmoidoscope Disinfection StandNZA · Traditional | 06/17/1986SE |
| K851149 | Key Med Transendoscopic Vascular Detector TVD-1JAF · Traditional | 11/26/1985SE |
| K854304 | Keymed Office CouchFPO · Traditional | 11/12/1985SE |
Questions and answers
When was Olympus Flushing Pump Ofp Model: OFP-1 cleared by the FDA?
Olympus Flushing Pump Ofp Model: OFP-1 (K100803) received a 510(k) decision of Substantially Equivalent on April 22, 2010, 31 days after the submission was received.
What is the product code of K100803?
The FDA product code is FEQ – Pump, Air, Non-Manual, For Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.