Home / 510(k) Clearances / K042287

510(k) K042287

UNIPLAIN & UNICHROM by United Medical Industries Co. , Ltd. — Product Code GAL

K042287 is an FDA 510(k) premarket notification submitted by United Medical Industries Co. , Ltd. for the device "UNIPLAIN & UNICHROM". The FDA issued a decision of Substantially Equivalent on September 7, 2005. The device falls under product code GAL (Suture, Absorbable, Natural), a Class II device regulated under 21 CFR 878.4830. United Medical Industries Co. , Ltd. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2005
Date Received
August 24, 2004
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 United Medical Industries Co. , Ltd.

  • K072646 — UNICAPRONE (November 7, 2007)
  • K072644 — UNICRYL QUICK (November 7, 2007)
  • K072645 — UNIGLACTIN (November 7, 2007)
  • K042288 — UNICRYL (December 27, 2004)
  • K042285 — UNICRYL M (December 10, 2004)
  • K042284 — UNIMIDE (December 3, 2004)
  • K042282 — UNISILK (December 1, 2004)
  • K042286 — UNIESTER C (December 1, 2004)
  • K042283 — UNIPRO (December 1, 2004)

Other clearances for product code GAL

  • K142656 — Surgical Gut Suture (January 29, 2015)
  • K072930 — DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT (April 30, 2008)
  • 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