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510(k) K994002

PLAIN/CHROMIC CATGUT by Trading Consultants and Distributors Intl., Inc. — Product Code GAL

K994002 is an FDA 510(k) premarket notification submitted by Trading Consultants and Distributors Intl., Inc. for the device "PLAIN/CHROMIC CATGUT". The FDA issued a decision of Substantially Equivalent on February 4, 2000. The device falls under product code GAL (Suture, Absorbable, Natural), a Class II device regulated under 21 CFR 878.4830. Trading Consultants and Distributors Intl., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2000
Date Received
November 24, 1999
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 Trading Consultants and Distributors Intl., Inc.

  • K994001 — POLYGLYCOLIC ACID (February 9, 2000)
  • K994000 — POLYESTER (February 4, 2000)
  • K993997 — POLYPROPYLENE (February 4, 2000)
  • K993998 — NYLON (February 4, 2000)
  • K993999 — SILK (February 4, 2000)

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