Fujinon Evl-F (Tentative) and Trocar
FDA 510(k) K902197 · Fujinon, Inc.
510(k) numberK902197
Submission
- Device name
- Fujinon Evl-F (Tentative) and Trocar
- Applicant
- Fujinon, Inc.
Washington, DC, US - Received
- May 16, 1990
- Decision date
- March 5, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HET – Laparoscope, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1720
- Specialty
- Obstetrics/Gynecology
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| K200638 | LAP-iX Suction IrrigationHET · Special | Sejong Medical Co., Ltd. | 04/03/2020SE |
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More from 270surgical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K120446 | Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2FDS · Traditional | 08/13/2012SE |
| K112391 | Fujinon ColonoscopesFDF · Special | 07/26/2012SE |
| K102466 | Fujinon EPX-4440HD Digital Video ProcessorFET · Traditional | 05/25/2011SE |
| K111243 | Fujinon Ultrasonic ProcessorFDS · Special | 05/16/2011SE |
| K091773 | Fujinon Sterile OvertubesFED · Special | 08/07/2009SE |
| K090116 | Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15FDF · Traditional | 04/22/2009SE |
| K063316 | Fujinon Model EG-530N Trans Nasal InsertionFDS · Traditional | 03/16/2007SE |
| K063847 | Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700FDS · Traditional | 03/01/2007SE |
| K050907 | Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270PEOQ · Traditional | 05/19/2005SE |
| K042043 | Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5FDS · Traditional | 11/24/2004SE |
Questions and answers
When was Fujinon Evl-F (Tentative) and Trocar cleared by the FDA?
Fujinon Evl-F (Tentative) and Trocar (K902197) received a 510(k) decision of Substantially Equivalent on March 5, 1991, 293 days after the submission was received.
What is the product code of K902197?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.