Spirtos Coaxial Catheter Set
FDA 510(k) K896524 · Cook Ob/Gyn
510(k) numberK896524
Submission
- Device name
- Spirtos Coaxial Catheter Set
- Applicant
- Cook Ob/Gyn
Spencer, IN, US - Received
- November 15, 1989
- Decision date
- September 5, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Spirtos Coaxial Catheter Set cleared by the FDA?
Spirtos Coaxial Catheter Set (K896524) received a 510(k) decision of Substantially Equivalent on September 5, 1990, 294 days after the submission was received.
What is the product code of K896524?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.