Hydromat Trumpet Valve and Tubing Set for Laparoscopic Suction and Irrigation
FDA 510(k) K940462 · KARL STORZ Endoscopy-America, Inc.
510(k) numberK940462
Submission
- Device name
- Hydromat Trumpet Valve and Tubing Set for Laparoscopic Suction and Irrigation
- Applicant
- KARL STORZ Endoscopy-America, Inc.
Kennesaw, GA, US - Received
- February 2, 1994
- Decision date
- May 10, 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 Hydromat Trumpet Valve and Tubing Set for Laparoscopic Suction and Irrigation cleared by the FDA?
Hydromat Trumpet Valve and Tubing Set for Laparoscopic Suction and Irrigation (K940462) received a 510(k) decision of Substantially Equivalent on May 10, 1994, 97 days after the submission was received.
What is the product code of K940462?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.