510(k) K001789
K001789 is an FDA 510(k) premarket notification submitted by W. L. Gore & Associates, Inc. for the device "SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL". The FDA issued a decision of Substantially Equivalent on July 6, 2000. The device falls under product code OXD (Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement), a Class II device regulated under 21 CFR 878.3300. W. L. Gore & Associates, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 6, 2000
- Date Received
- June 13, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type
For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.