Interceptre Laparoscopic Instruments
FDA 510(k) K970151 · Smith & Nephew, Inc.
510(k) numberK970151
Submission
- Device name
- Interceptre Laparoscopic Instruments
- Applicant
- Smith & Nephew, Inc.
Mansfield, MA, US - Received
- January 15, 1997
- Decision date
- March 18, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HET – Laparoscope, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1720
- Specialty
- Obstetrics/Gynecology
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Questions and answers
When was Interceptre Laparoscopic Instruments cleared by the FDA?
Interceptre Laparoscopic Instruments (K970151) received a 510(k) decision of Substantially Equivalent on March 18, 1997, 62 days after the submission was received.
What is the product code of K970151?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.