510(k) K170767
K170767 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "Surgical Stainless Steel Suture, Stainless Steel Suture". The FDA issued a decision of Substantially Equivalent on November 1, 2017. The device falls under product code GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile), a Class II device regulated under 21 CFR 878.4495. ETHICON, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 2017
- Date Received
- March 14, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- Device Class
- Class II
- Regulation Number
- 878.4495
- Review Panel
- SU
- Submission Type