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510(k) K922630

MOPYLEN by S. Jackson, Inc. — Product Code GAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1992
Date Received
June 3, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class
Class II
Regulation Number
878.5010
Review Panel
SU
Submission Type

Other clearances by S. Jackson, Inc.

  • K080216 — SUPRAMESH EXTRA (September 15, 2008)
  • K973379 — STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS (September 25, 1997)
  • K931614 — MOPYLEN SUTURE (December 17, 1993)
  • K931613 — SUPRAMID SUTURE (December 17, 1993)
  • K931612 — NYLAMID SUTURE (December 17, 1993)
  • K912429 — N80-838 SUPRAMID EXTRA SUTURE (October 2, 1991)
  • K904052 — SUPRAMID EXTRA SUTURES (October 25, 1990)
  • K852011 — NYLAMID MESH PAD FULL & HALF (June 11, 1985)
  • K831725 — FOIL IN 3 FORMS-NON-STERILE SHEETS (August 16, 1983)
  • K831724 — CHIN (MENTOPLASTY) IMPLANTS (August 12, 1983)

Other clearances for product code GAW

  • K233355 — Cypris eXact Suturing System (January 12, 2024)
  • K230746 — Non absorbable Surgical Polypropylene Suture (September 14, 2023)
  • K221280 — Vesseal (December 9, 2022)
  • K211178 — DURAMESH Mesh Suture (September 2, 2022)
  • K192953 — APTOS Threads – Polypropylene Surgical Sutures (August 27, 2020)
  • K193530 — Deklene MAXX (March 19, 2020)
  • K191299 — Silhouette Featherlift / Silhouette Lift (June 14, 2019)
  • K173747 — REXLENE (December 21, 2018)
  • K180321 — Aesculap Optilene Nonabsorbable Suture (March 7, 2018)
  • K173644 — Gazelle Polypropylene Suture and Delivery Device (February 15, 2018)