Davol Scope Irrigation System
FDA 510(k) K901288 · C.R. Bard, Inc.
510(k) numberK901288
Submission
- Device name
- Davol Scope Irrigation System
- Applicant
- C.R. Bard, Inc.
Murray Hill, NJ, US - Received
- March 20, 1990
- Decision date
- October 10, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HIG – Insufflator, Hysteroscopic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1700
- Specialty
- Obstetrics/Gynecology
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Questions and answers
When was Davol Scope Irrigation System cleared by the FDA?
Davol Scope Irrigation System (K901288) received a 510(k) decision of Substantially Equivalent on October 10, 1990, 204 days after the submission was received.
What is the product code of K901288?
The FDA product code is HIG – Insufflator, Hysteroscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1700.