Ligaclip Endoscopic Rotating Multiple Clip Applier
FDA 510(k) K934174 · ETHICON, Inc.
510(k) numberK934174
Submission
- Device name
- Ligaclip Endoscopic Rotating Multiple Clip Applier
- Applicant
- ETHICON, Inc.
Cincinnati, OH, US - Received
- August 27, 1993
- Decision date
- March 9, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCW – Endoscopic Tissue Approximation Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.
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Questions and answers
When was Ligaclip Endoscopic Rotating Multiple Clip Applier cleared by the FDA?
Ligaclip Endoscopic Rotating Multiple Clip Applier (K934174) received a 510(k) decision of Substantially Equivalent on March 9, 1994, 194 days after the submission was received.
What is the product code of K934174?
The FDA product code is OCW – Endoscopic Tissue Approximation Device, a Class II (moderate risk) device regulated under 21 CFR 876.1500.