510(k) K771412
K771412 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "LIGACLIP MULTIPLE CLIP APPLIER". The FDA issued a decision of Substantially Equivalent on November 28, 1977. The device falls under product code GDO (Applier, Surgical, Clip), a Class I device regulated under 21 CFR 878.4800. ETHICON, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 28, 1977
- Date Received
- August 1, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applier, Surgical, Clip
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type