Diamond-Sharp(R) Trocars
FDA 510(k) K924148 · Snowden-Pencer
510(k) numberK924148
Submission
- Device name
- Diamond-Sharp(R) Trocars
- Applicant
- Snowden-Pencer
Tucker, GA, US - Received
- August 18, 1992
- Decision date
- February 28, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HFI – Coagulator, Culdoscopic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4160
- Specialty
- Obstetrics/Gynecology
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Questions and answers
When was Diamond-Sharp(R) Trocars cleared by the FDA?
Diamond-Sharp(R) Trocars (K924148) received a 510(k) decision of Substantially Equivalent on February 28, 1994, 559 days after the submission was received.
What is the product code of K924148?
The FDA product code is HFI – Coagulator, Culdoscopic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4160.