Tristar LP Torcar with Low Profile Threaded Sleeve
FDA 510(k) K965045 · Ethicon Endo-Surgery, Inc.
510(k) numberK965045
Submission
- Device name
- Tristar LP Torcar with Low Profile Threaded Sleeve
- Applicant
- Ethicon Endo-Surgery, Inc.
Cincinnati, OH, US - Received
- December 17, 1996
- Decision date
- May 5, 1997
- 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 Tristar LP Torcar with Low Profile Threaded Sleeve cleared by the FDA?
Tristar LP Torcar with Low Profile Threaded Sleeve (K965045) received a 510(k) decision of Substantially Equivalent on May 5, 1997, 139 days after the submission was received.
What is the product code of K965045?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.