Hydroflex HD Hysteroscopic Distention System,Model #'S 0025360, 0025370, 0025000
FDA 510(k) K982867 · Davol Inc., Sub. C. R. Bard, Inc.
510(k) numberK982867
Submission
- Device name
- Hydroflex HD Hysteroscopic Distention System,Model #'S 0025360, 0025370, 0025000
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
Canston, RI, US - Received
- August 14, 1998
- Decision date
- February 19, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 Hydroflex HD Hysteroscopic Distention System,Model #'S 0025360, 0025370, 0025000 cleared by the FDA?
Hydroflex HD Hysteroscopic Distention System,Model #'S 0025360, 0025370, 0025000 (K982867) received a 510(k) decision of Substantially Equivalent on February 19, 1999, 189 days after the submission was received.
What is the product code of K982867?
The FDA product code is HIG – Insufflator, Hysteroscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1700.