Reprocessed Disposable Trocars
FDA 510(k) K022743 · Medical Device Services
510(k) numberK022743
Submission
- Device name
- Reprocessed Disposable Trocars
- 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
- KAB – Trocar, Laryngeal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Specialty
- Ear, Nose, Throat
More from Medical Device Services
| 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 |
| K022748 | Reprocssed Used Disposable Endoscopic Scissors and GraspersHET · 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 Reprocessed Disposable Trocars cleared by the FDA?
Reprocessed Disposable Trocars (K022743) 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 K022743?
The FDA product code is KAB – Trocar, Laryngeal, a Class I (low risk) device regulated under 21 CFR 874.4420.