Laparoscope and Accessories for OB/GYN
FDA 510(k) K950232 · Olympus America, Inc.
510(k) numberK950232
Submission
- Device name
- Laparoscope and Accessories for OB/GYN
- Applicant
- Olympus America, Inc.
Lake Success, NY, US - Received
- January 9, 1995
- Decision date
- March 16, 1995
- 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 Laparoscope and Accessories for OB/GYN cleared by the FDA?
Laparoscope and Accessories for OB/GYN (K950232) received a 510(k) decision of Substantially Equivalent on March 16, 1995, 66 days after the submission was received.
What is the product code of K950232?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.