Ksea Rigid Culdoscope and Accessories
FDA 510(k) K993804 · KARL STORZ Endoscopy-America, Inc.
510(k) numberK993804
Submission
- Device name
- Ksea Rigid Culdoscope and Accessories
- Applicant
- KARL STORZ Endoscopy-America, Inc.
Culver City, CA, US - Received
- November 9, 1999
- Decision date
- February 7, 2000
- 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 Ksea Rigid Culdoscope and Accessories cleared by the FDA?
Ksea Rigid Culdoscope and Accessories (K993804) received a 510(k) decision of Substantially Equivalent on February 7, 2000, 90 days after the submission was received.
What is the product code of K993804?
The FDA product code is HEW – Culdoscope (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1640.