Home / 510(k) Clearances / K111006

510(k) K111006

CI-SNAP WOUND CARE SYSTEM by Spiracur, Inc. — Product Code OKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2011
Date Received
April 11, 2011
Clearance Type
Traditional
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)
  • K111393 — SNAP (R) WOUND CARE SYSTEM (July 28, 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)