Smith & Nephew Dyonics Microlaparoscope
FDA 510(k) K982149 · Smith & Nephew, Inc.
510(k) numberK982149
Submission
- Device name
- Smith & Nephew Dyonics Microlaparoscope
- Applicant
- Smith & Nephew, Inc.
Andover, MA, US - Received
- June 18, 1998
- Decision date
- September 10, 1998
- 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 Smith & Nephew Dyonics Microlaparoscope cleared by the FDA?
Smith & Nephew Dyonics Microlaparoscope (K982149) received a 510(k) decision of Substantially Equivalent on September 10, 1998, 84 days after the submission was received.
What is the product code of K982149?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.