TruClear Elite Hysteroscope
FDA 510(k) K180496 · Covidien
510(k) numberK180496
Submission
- Device name
- TruClear Elite Hysteroscope
- Applicant
- Covidien
North Haven, CT, US - Received
- February 26, 2018
- Decision date
- August 29, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HIH – Hysteroscope (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1690
- Specialty
- Obstetrics/Gynecology
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Questions and answers
When was TruClear Elite Hysteroscope cleared by the FDA?
TruClear Elite Hysteroscope (K180496) received a 510(k) decision of Substantially Equivalent on August 29, 2018, 184 days after the submission was received.
What is the product code of K180496?
The FDA product code is HIH – Hysteroscope (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1690.