Scissors, Grasping Forceps, Needle Holders, Dissectors
FDA 510(k) K940709 · Baxter Healthcare Corp
510(k) numberK940709
Submission
- Device name
- Scissors, Grasping Forceps, Needle Holders, Dissectors
- Applicant
- Baxter Healthcare Corp
Deerfield, IL, US - Received
- February 17, 1994
- Decision date
- May 19, 1994
- 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 Scissors, Grasping Forceps, Needle Holders, Dissectors cleared by the FDA?
Scissors, Grasping Forceps, Needle Holders, Dissectors (K940709) received a 510(k) decision of Substantially Equivalent on May 19, 1994, 91 days after the submission was received.
What is the product code of K940709?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.