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510(k) K020597

SERRALGUT by Serral, S.A. DE C.V. — Product Code GAL

K020597 is an FDA 510(k) premarket notification submitted by Serral, S.A. DE C.V. for the device "SERRALGUT". The FDA issued a decision of Substantially Equivalent on August 14, 2002. The device falls under product code GAL (Suture, Absorbable, Natural), a Class II device regulated under 21 CFR 878.4830. Serral, S.A. DE C.V. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2002
Date Received
February 22, 2002
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 Serral, S.A. DE C.V.

  • K033762 — SERRALAPG (March 15, 2004)
  • K020902 — SERRALESTER (May 20, 2002)
  • K020901 — SERRALSILK (April 26, 2002)
  • K020146 — SERRALNYL (April 15, 2002)
  • K020265 — SERRALENE, MODEL CATALOG NO 1S (March 8, 2002)

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)
  • 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