Trocars, Trocar Sleeves and Reduction Sleeves
FDA 510(k) K942389 · Hogan & Hartson
510(k) numberK942389
Submission
- Device name
- Trocars, Trocar Sleeves and Reduction Sleeves
- Applicant
- Hogan & Hartson
Washington, DC, US - Received
- May 18, 1994
- Decision date
- February 16, 1996
- 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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Questions and answers
When was Trocars, Trocar Sleeves and Reduction Sleeves cleared by the FDA?
Trocars, Trocar Sleeves and Reduction Sleeves (K942389) received a 510(k) decision of Substantially Equivalent on February 16, 1996, 639 days after the submission was received.
What is the product code of K942389?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.