510(k) K051950
K051950 is an FDA 510(k) premarket notification submitted by Ethicon Endo-Surgery, Inc. for the device "INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321". The FDA issued a decision of Substantially Equivalent on October 7, 2005. The device falls under product code MND (Ligator, Esophageal), a Class II device regulated under 21 CFR 876.4400. Ethicon Endo-Surgery, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 7, 2005
- Date Received
- July 18, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ligator, Esophageal
- Device Class
- Class II
- Regulation Number
- 876.4400
- Review Panel
- GU
- Submission Type