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510(k) K072930

DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT by Demetech Corp. — Product Code GAL

K072930 is an FDA 510(k) premarket notification submitted by Demetech Corp. for the device "DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT". The FDA issued a decision of Substantially Equivalent on April 30, 2008. The device falls under product code GAL (Suture, Absorbable, Natural), a Class II device regulated under 21 CFR 878.4830. Demetech Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2008
Date Received
October 16, 2007
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 Demetech Corp.

  • K141007 — DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE (September 25, 2014)
  • K123940 — DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE (May 30, 2014)
  • K130083 — DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE (July 17, 2013)
  • K082097 — DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE (January 8, 2010)
  • K043330 — POLYPROPILENE SURGICAL SUTURES (May 16, 2005)
  • K043539 — DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES (April 6, 2005)
  • K033550 — DXL CALSCAN (May 5, 2004)
  • K023030 — DEMETECH POLYESTER NONABSORBABLE SUTURE (June 18, 2003)
  • K023028 — DEMETECH NYLON NONABSORBABLE SUTURE (June 18, 2003)
  • K023029 — DEMETECH SILK NONABSORBABLE SUTURE (November 25, 2002)

Other clearances for product code GAL

  • K142656 — Surgical Gut Suture (January 29, 2015)
  • 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)
  • K993695 — LIGA-LOOP SUTURE APPLICATOR (April 13, 2000)

FDA data resources