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510(k) K930944

LUKENS SURGICAL GUT SUTURE by Lukens Medical Corp. — Product Code GAL

K930944 is an FDA 510(k) premarket notification submitted by Lukens Medical Corp. for the device "LUKENS SURGICAL GUT SUTURE". The FDA issued a decision of Substantially Equivalent on December 17, 1993. The device falls under product code GAL (Suture, Absorbable, Natural), a Class II device regulated under 21 CFR 878.4830. 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, Absorbable, Natural
Device Class
Class II
Regulation Number
878.4830
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)
  • 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)
  • K930943 — LUKENS NYLON SURGICAL SUTURE (December 17, 1993)
  • K904535 — LU-TEX II (January 30, 1991)

Other clearances for product code GAL

  • K142656 — Surgical Gut Suture (January 29, 2015)
  • K072930 — DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT (April 30, 2008)
  • K042287 — UNIPLAIN & UNICHROM (September 7, 2005)
  • K042897 — AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE (November 19, 2004)
  • K030227 — SUTURTEK FASTCLOSE SUTURING DEVICE (March 17, 2003)
  • K020597 — SERRALGUT (August 14, 2002)
  • K021043 — GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC (June 21, 2002)
  • K011105 — SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE (May 30, 2001)
  • K001299 — PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP (June 23, 2000)
  • K000542 — PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP (April 28, 2000)

FDA data resources