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510(k) K071111

NON-ABSORBABLE SILK SUTURE by Arrow Intl., Inc. — Product Code GAP

K071111 is an FDA 510(k) premarket notification submitted by Arrow Intl., Inc. for the device "NON-ABSORBABLE SILK SUTURE". The FDA issued a decision of Substantially Equivalent on July 17, 2007. The device falls under product code GAP (Suture, Nonabsorbable, Silk), a Class II device regulated under 21 CFR 878.5030. Arrow Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2007
Date Received
April 20, 2007
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 Arrow Intl., Inc.

  • K100635 — ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) (August 27, 2010)
  • K093050 — ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 (December 18, 2009)
  • K071491 — ARROW INTERNATIONAL, INC., SURGICAL DRAPES (October 10, 2007)
  • K071998 — ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT (September 26, 2007)
  • K060309 — AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES (April 6, 2006)
  • K042126 — PICC (August 27, 2004)
  • K041153 — SHARPSAWAY II LOCKING DISPOSABLE CUP (July 12, 2004)
  • K040801 — INTRA-AORTIC BALLOON (IAB) (May 6, 2004)
  • K040802 — HEMOSONIC 200HEMODYNAMIC MONITOR (April 28, 2004)
  • K040100 — ARROW ECHOGENIC INTRODUCER NEEDLE (March 1, 2004)

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)
  • K053638 — MANI NEEDLE & SUTURE PACK (SILK) (May 19, 2006)

FDA data resources