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510(k) K904535

LU-TEX II by Lukens Medical Corp. — Product Code GAS

K904535 is an FDA 510(k) premarket notification submitted by Lukens Medical Corp. for the device "LU-TEX II". The FDA issued a decision of Substantially Equivalent on January 30, 1991. The device falls under product code GAS (Suture, Nonabsorbable, Synthetic, Polyester), a Class II device regulated under 21 CFR 878.5000. Lukens Medical Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1991
Date Received
October 4, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyester
Device Class
Class II
Regulation Number
878.5000
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)
  • K930943 — LUKENS NYLON SURGICAL SUTURE (December 17, 1993)
  • K930941 — LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE (December 17, 1993)
  • K930942 — LUKENS SILK SURGICAL SUTURE (December 17, 1993)

Other clearances for product code GAS

  • K203081 — RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture (November 24, 2020)
  • K203120 — RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK (November 24, 2020)
  • K091018 — ARTHREX BIOWIRE (July 30, 2010)
  • K002261 — MR-III (October 23, 2000)
  • K953128 — SUTURE CORD (February 9, 1996)
  • K923161 — BRAIDED POLYESTER SUTURE MATERIAL (December 30, 1992)
  • K913101 — PETERS CARDIOFLON(TM) SUTURE (August 12, 1992)
  • K915089 — MITEK QUICKANCHOR(TM), MODIFICATION (February 3, 1992)
  • K915081 — MITEK SNAP PAK(TM), MODIFICATION (January 31, 1992)
  • K903175 — ADVANCE SUTURE NONABSORBABLE DACRON SUTURE (July 26, 1991)

FDA data resources