Flexible Tip Thoracoscope/Laparoscope
FDA 510(k) K915857 · Olympus Corp.
510(k) numberK915857
Submission
- Device name
- Flexible Tip Thoracoscope/Laparoscope
- Applicant
- Olympus Corp.
Lake Success, NY, US - Received
- December 27, 1991
- Decision date
- March 11, 1994
- 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 Flexible Tip Thoracoscope/Laparoscope cleared by the FDA?
Flexible Tip Thoracoscope/Laparoscope (K915857) received a 510(k) decision of Substantially Equivalent on March 11, 1994, 805 days after the submission was received.
What is the product code of K915857?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.