Home / 510(k) Clearances / K000542

510(k) K000542

PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP by Arc Medical Supplies (Beijing) Co, Ltd. — Product Code GAL

K000542 is an FDA 510(k) premarket notification submitted by Arc Medical Supplies (Beijing) Co, Ltd. for the device "PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP". The FDA issued a decision of Substantially Equivalent on April 28, 2000. The device falls under product code GAL (Suture, Absorbable, Natural), a Class II device regulated under 21 CFR 878.4830. Arc Medical Supplies (Beijing) Co, Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2000
Date Received
February 17, 2000
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 Arc Medical Supplies (Beijing) Co, Ltd.

  • K022666 — PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P. (October 9, 2002)
  • K022664 — PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P. (September 10, 2002)
  • K000541 — SILK NONABSORBABLE SURGICAL SUTURES, USP (April 28, 2000)
  • K000540 — POLYESTER NONABSORBABLE SURGICAL SUTURES, USP (April 27, 2000)
  • K000539 — NYLON NONABSORBABLE SURGICAL SUTURES, USP (April 27, 2000)
  • K000537 — POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP (April 27, 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)
  • K993695 — LIGA-LOOP SUTURE APPLICATOR (April 13, 2000)

FDA data resources