Rigid Culdoscope and Accessories
FDA 510(k) K980972 · Circon Corp.
510(k) numberK980972
Submission
- Device name
- Rigid Culdoscope and Accessories
- Applicant
- Circon Corp.
Santa Barbara, CA, US - Received
- March 16, 1998
- Decision date
- June 12, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HEW – Culdoscope (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1640
- Specialty
- Obstetrics/Gynecology
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Questions and answers
When was Rigid Culdoscope and Accessories cleared by the FDA?
Rigid Culdoscope and Accessories (K980972) received a 510(k) decision of Substantially Equivalent on June 12, 1998, 88 days after the submission was received.
What is the product code of K980972?
The FDA product code is HEW – Culdoscope (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1640.