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510(k) K930943

LUKENS NYLON SURGICAL SUTURE by Lukens Medical Corp. — Product Code GAR

K930943 is an FDA 510(k) premarket notification submitted by Lukens Medical Corp. for the device "LUKENS NYLON SURGICAL SUTURE". The FDA issued a decision of Substantially Equivalent on December 17, 1993. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. Lukens Medical Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1993
Date Received
February 23, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyamide
Device Class
Class II
Regulation Number
878.5020
Review Panel
SU
Submission Type

Other clearances by Lukens Medical Corp.

  • K965162 — LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRA (February 12, 1997)
  • K930945 — BRAIDED POLYESTER SURGICAL SUTURE (December 17, 1993)
  • K930944 — LUKENS SURGICAL GUT SUTURE (December 17, 1993)
  • K930940 — LUKENS STAINLESS STEEL SURGICAL SUTURE (December 17, 1993)
  • K930941 — LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE (December 17, 1993)
  • K930942 — LUKENS SILK SURGICAL SUTURE (December 17, 1993)
  • K904535 — LU-TEX II (January 30, 1991)

Other clearances for product code GAR

  • K261484 — Tissue Approximation System (June 3, 2026)
  • K220980 — Tissue Approximation System (TAS) (July 5, 2023)
  • K212888 — Golnit Nylon Monofilament Suture (March 31, 2022)
  • K212603 — Non Absorbable Surgical Nylon Suture (December 22, 2021)
  • K192420 — Crownjun Nylon Suture (May 29, 2020)
  • K161633 — REXLON, REXSIL (March 2, 2017)
  • K151165 — Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture (February 17, 2016)
  • K152795 — RiverLon (Nylon) Suture (October 28, 2015)
  • K123034 — VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED (May 28, 2013)
  • K081366 — KUMAR T-ANCHORS HERNIA SET (July 15, 2008)

FDA data resources