Oes Laparo-Thoraco Videoscope (Rigid)
FDA 510(k) K955456 · Olympus America, Inc.
510(k) numberK955456
Submission
- Device name
- Oes Laparo-Thoraco Videoscope (Rigid)
- Applicant
- Olympus America, Inc.
Melville, NY, US - Received
- November 29, 1995
- Decision date
- February 22, 1996
- 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 Oes Laparo-Thoraco Videoscope (Rigid) cleared by the FDA?
Oes Laparo-Thoraco Videoscope (Rigid) (K955456) received a 510(k) decision of Substantially Equivalent on February 22, 1996, 85 days after the submission was received.
What is the product code of K955456?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.