510(k) DEN080011

SNAP WOUND CARE DEVICE by Spiracur, Inc. — Product Code OKO

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: August 7, 2009
Date Received: November 3, 2008
Clearance Type: Post-NSE
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)
K111006 — CI-SNAP WOUND CARE SYSTEM (July 21, 2011)

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)