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510(k) K111393

SNAP (R) WOUND CARE SYSTEM by Spiracur, Inc. — Product Code OKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2011
Date Received
May 18, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Negative Pressure Wound Therapy Non-Powered Suction Apparatus
Device Class
Class II
Regulation Number
878.4683
Review Panel
SU
Submission Type

A non-powered suction apparatus indicated for negative pressure wound therapy (npwt) that is intended for wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials.

Other clearances by Spiracur, Inc.

  • K151710 — SNaP Wound Care System (November 19, 2015)
  • K142272 — SNaP Wound Care System (November 25, 2014)
  • K132080 — SNAP WOUND CARE SYSTEM (March 12, 2014)
  • K133137 — CISNAP CLOSED INCISION SYSTEM (February 25, 2014)
  • K113032 — SNAP WOUND CARE SYSTEM (December 1, 2011)
  • K112341 — SNAP WOUND CARE SYSTEM (August 29, 2011)
  • K111006 — CI-SNAP WOUND CARE SYSTEM (July 21, 2011)
  • DEN080011 — SNAP WOUND CARE DEVICE (August 7, 2009)

Other clearances for product code OKO

  • K251156 — NPseal (May 15, 2025)
  • K250708 — NPseal (April 8, 2025)
  • K241522 — NPseal (20 and 25) (August 15, 2024)
  • K240244 — NPseal (Small, Medium, Large) (February 29, 2024)
  • K212971 — NPseal (February 10, 2022)
  • K211130 — NPseal (May 14, 2021)
  • K200305 — NPseal (May 26, 2020)
  • K193185 — Anscare SIMO Negative Pressure Wound Therapy (NPWT) System (May 4, 2020)
  • K151710 — SNaP Wound Care System (November 19, 2015)
  • K142272 — SNaP Wound Care System (November 25, 2014)