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510(k) K903029

STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE by Look, Inc. — Product Code GAR

K903029 is an FDA 510(k) premarket notification submitted by Look, Inc. for the device "STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE". The FDA issued a decision of Substantially Equivalent on October 25, 1990. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. Look, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1990
Date Received
July 10, 1990
Clearance Type
Traditional
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

Other clearances by Look, Inc.

  • K943949 — POLYVIOLENE SURGICL SUTURE (November 10, 1994)
  • K933686 — LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE (December 23, 1993)
  • K926586 — REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES (December 22, 1993)
  • K926588 — REVISED LABELING FOR POLYPROPYLENE SUTURE (December 17, 1993)
  • K926587 — REVISED LABELING FOR NYLON SUTURE (POLYAMIDE) (December 17, 1993)
  • K926168 — SILK SUTURES-REVISED LABELING (December 17, 1993)
  • K926167 — POLYVIOLENE SUTURE-REVISED LABELING (December 17, 1993)
  • K913530 — LOOK VISCODISSECTOR (October 21, 1991)
  • K903584 — POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES (October 11, 1990)
  • K904054 — POLYVIOLENE(TM) SUTURE (October 3, 1990)

Other clearances for product code GAR

  • K261484 — Tissue Approximation System (June 3, 2026)
  • 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