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510(k) K020901

SERRALSILK by Serral, S.A. DE C.V. — Product Code GAP

K020901 is an FDA 510(k) premarket notification submitted by Serral, S.A. DE C.V. for the device "SERRALSILK". The FDA issued a decision of Substantially Equivalent on April 26, 2002. The device falls under product code GAP (Suture, Nonabsorbable, Silk), a Class II device regulated under 21 CFR 878.5030. Serral, S.A. DE C.V. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2002
Date Received
March 20, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Silk
Device Class
Class II
Regulation Number
878.5030
Review Panel
SU
Submission Type

Other clearances by Serral, S.A. DE C.V.

  • K033762 — SERRALAPG (March 15, 2004)
  • K020597 — SERRALGUT (August 14, 2002)
  • K020902 — SERRALESTER (May 20, 2002)
  • K020146 — SERRALNYL (April 15, 2002)
  • K020265 — SERRALENE, MODEL CATALOG NO 1S (March 8, 2002)

Other clearances for product code GAP

  • K241486 — Sofsilk™ Coated Braided Silk Suture (December 3, 2024)
  • K222944 — SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Sutur (October 18, 2024)
  • K232355 — Non absorbable Surgical Silk Suture (January 16, 2024)
  • K221767 — Surgical Sutures with or without Needle (July 31, 2023)
  • K180701 — SafePath Suturing System (June 25, 2018)
  • K172149 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbabl (October 20, 2017)
  • K162396 — SILK Surgical Suture (November 23, 2016)
  • K160623 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbabl (May 31, 2016)
  • K080684 — WG-SURGICAL SUTURES WITH NEEDLE (June 9, 2008)
  • K071111 — NON-ABSORBABLE SILK SUTURE (July 17, 2007)

FDA data resources