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510(k) K170767

Surgical Stainless Steel Suture, Stainless Steel Suture by Ethicon, Inc. — Product Code GAQ

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

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  • K140127 — FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP (May 28, 2014)
  • K081060 — FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 (December 24, 2008)
  • K082828 — SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE (October 14, 2008)
  • K063603 — SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 (February 7, 2007)
  • K042606 — MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE (May 27, 2005)
  • K041333 — SYNTHES (USA) TITANIUM WIRE (August 27, 2004)