Reprocssed Used Disposable Endoscopic Scissors and Graspers
FDA 510(k) K022748 · Medical Device Services
510(k) numberK022748
Submission
- Device name
- Reprocssed Used Disposable Endoscopic Scissors and Graspers
- Applicant
- Medical Device Services
St. George, UT, US - Received
- August 19, 2002
- Decision date
- October 9, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| K221642 | SIRIUS Endoscope SystemHET · Traditional | Precision Robotics (Hong Kong) Limited | 12/12/2022SE |
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| K200638 | LAP-iX Suction IrrigationHET · Special | Sejong Medical Co., Ltd. | 04/03/2020SE |
| K190190 | WV1 EndoscopeHET · Traditional | 270surgical , Ltd. | 11/01/2019SE |
More from 270surgical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K022753 | Reprocesses Used Disposable Sequential Compression Sleeves/WrapsJOW · Traditional | 11/14/2002SE |
| K022751 | Reprocessed Used Disposable Hot and Cold Biopsy ForcepsKGE · Traditional | 11/04/2002SE |
| K022743 | Reprocessed Disposable TrocarsKAB · Traditional | 10/09/2002SE |
| K022744 | Reprocessed Used Disposable Arthroscopic Blades and BursHWE · Traditional | 09/18/2002SE |
| K012979 | Compressible Limb SleeveJOW · Traditional | 05/08/2002SE |
Questions and answers
When was Reprocssed Used Disposable Endoscopic Scissors and Graspers cleared by the FDA?
Reprocssed Used Disposable Endoscopic Scissors and Graspers (K022748) received a 510(k) decision of Substantially Equivalent on October 9, 2002, 51 days after the submission was received.
What is the product code of K022748?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.