Stryker Operating Laparoscope
FDA 510(k) K943100 · Stryker Endoscopy
510(k) numberK943100
Submission
- Device name
- Stryker Operating Laparoscope
- Applicant
- Stryker Endoscopy
San Jose, CA, US - Received
- June 29, 1994
- Decision date
- August 10, 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 Stryker Operating Laparoscope cleared by the FDA?
Stryker Operating Laparoscope (K943100) received a 510(k) decision of Substantially Equivalent on August 10, 1995, 407 days after the submission was received.
What is the product code of K943100?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.