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510(k) K943949

POLYVIOLENE SURGICL SUTURE by Look, Inc. — Product Code GAT

K943949 is an FDA 510(k) premarket notification submitted by Look, Inc. for the device "POLYVIOLENE SURGICL SUTURE". The FDA issued a decision of SN on November 10, 1994. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Look, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
November 10, 1994
Date Received
August 2, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type

Other clearances by Look, Inc.

  • 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)
  • K926168 — SILK SUTURES-REVISED LABELING (December 17, 1993)
  • K926587 — REVISED LABELING FOR NYLON SUTURE (POLYAMIDE) (December 17, 1993)
  • K926167 — POLYVIOLENE SUTURE-REVISED LABELING (December 17, 1993)
  • K913530 — LOOK VISCODISSECTOR (October 21, 1991)
  • K903029 — STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE (October 25, 1990)
  • K903584 — POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES (October 11, 1990)
  • K904054 — POLYVIOLENE(TM) SUTURE (October 3, 1990)

Other clearances for product code GAT

  • K261021 — EasyWhip Family (July 1, 2026)
  • K260775 — Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ (May 6, 2026)
  • K254275 — HyperSuture All Green Extension Line (March 23, 2026)
  • K254188 — Meniscus Versaflex (February 19, 2026)
  • K253145 — Pre-Sutured Tendon (October 22, 2025)
  • K253024 — ProZip Knotless Implant (October 16, 2025)
  • K252225 — PowerKnot High Strength Sutures (September 12, 2025)
  • K252201 — HS Fiber (August 13, 2025)
  • K242201 — HyperSuture White/Green Extension Line (March 27, 2025)
  • K241376 — HyperSuture All Blue Extension Line (August 9, 2024)

FDA data resources