TRUCLEAR Operative Hysteroscope 5C and Sheath 5C
FDA 510(k) K152143 · Smith & Nephew, Inc.
510(k) numberK152143
Submission
- Device name
- TRUCLEAR Operative Hysteroscope 5C and Sheath 5C
- Applicant
- Smith & Nephew, Inc.
Andover, MA, US - Received
- August 3, 2015
- Decision date
- September 2, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Operative Hysteroscope 5C and Sheath 5C cleared by the FDA?
TRUCLEAR Operative Hysteroscope 5C and Sheath 5C (K152143) received a 510(k) decision of Substantially Equivalent on September 2, 2015, 30 days after the submission was received.
What is the product code of K152143?
The FDA product code is HIH – Hysteroscope (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1690.