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510(k) K021043

GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC by Gramsmed, LLC — Product Code GAL

K021043 is an FDA 510(k) premarket notification submitted by Gramsmed, LLC for the device "GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC". The FDA issued a decision of Substantially Equivalent on June 21, 2002. The device falls under product code GAL (Suture, Absorbable, Natural), a Class II device regulated under 21 CFR 878.4830. Gramsmed, LLC has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2002
Date Received
April 1, 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 Gramsmed, LLC

  • K010672 — MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE (May 18, 2001)
  • K003017 — GRAMSORB SYNTHETIC ABSORBABLE SUTURE (March 13, 2001)
  • K003590 — GRAMS POLYESTER NONABSORBABLE SUTURE (March 5, 2001)
  • K002999 — GRAMS POLYPROPYLENE NONABSORBABLE SUTURE (December 18, 2000)
  • K003000 — GRAMS NYLON NONABSORBABLE SUTURE (December 18, 2000)
  • K003001 — GRAMS SILK NONABSORBABLE SUTURE (December 15, 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)
  • 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