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510(k) K943217

PLAIN CATGUT by Sutures , Ltd. — Product Code GAL

K943217 is an FDA 510(k) premarket notification submitted by Sutures , Ltd. for the device "PLAIN CATGUT". The FDA issued a decision of SN on December 5, 1994. The device falls under product code GAL (Suture, Absorbable, Natural), a Class II device regulated under 21 CFR 878.4830. Sutures , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
December 5, 1994
Date Received
July 5, 1994
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 Sutures , Ltd.

  • K990432 — SURGISORB (May 27, 1999)
  • K953609 — PRODEK (January 31, 1996)
  • K943223 — SURGIDEK B (December 5, 1994)
  • K943220 — SUTULENE (December 5, 1994)
  • K943222 — SURGIDEK S (December 5, 1994)
  • K943627 — SURGISILK (December 5, 1994)
  • K943221 — SURGIBOND (December 5, 1994)
  • K943216 — SURGIDEK (December 5, 1994)
  • K943218 — CHROMIC CATGUT (December 5, 1994)
  • K865038 — SURGISTEEL (June 30, 1987)

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