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510(k) K042367

NYLON THREADED NEEDLE by Aros Surgical Instruments Corp. — Product Code GAR

K042367 is an FDA 510(k) premarket notification submitted by Aros Surgical Instruments Corp. for the device "NYLON THREADED NEEDLE". The FDA issued a decision of Substantially Equivalent on October 14, 2004. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2004
Date Received
August 31, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyamide
Device Class
Class II
Regulation Number
878.5020
Review Panel
SU
Submission Type

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  • K220980 — Tissue Approximation System (TAS) (July 5, 2023)
  • K212888 — Golnit Nylon Monofilament Suture (March 31, 2022)
  • K212603 — Non Absorbable Surgical Nylon Suture (December 22, 2021)
  • K192420 — Crownjun Nylon Suture (May 29, 2020)
  • K161633 — REXLON, REXSIL (March 2, 2017)
  • K151165 — Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture (February 17, 2016)
  • K152795 — RiverLon (Nylon) Suture (October 28, 2015)
  • K123034 — VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED (May 28, 2013)
  • K081366 — KUMAR T-ANCHORS HERNIA SET (July 15, 2008)

FDA data resources