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FDA 510(k)

SNAP WOUND CARE SYSTEM

K-Number: K112341 · 2011-08-29

ApplicantSpiracur, Inc.
Decision Date2011-08-29
Product CodeOKO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SNAP WOUND CARE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spiracur, Inc.. It received FDA 510(k) clearance on 2011-08-29 under 510(k) number K112341. The device is classified under product code OKO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SNAP WOUND CARE SYSTEM?

SNAP WOUND CARE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-08-29. The listed applicant is Spiracur, Inc.. The 510(k) number is K112341.

When did SNAP WOUND CARE SYSTEM receive FDA 510(k) clearance?

SNAP WOUND CARE SYSTEM received FDA 510(k) clearance on 2011-08-29, under 510(k) number K112341.

Who is the listed applicant for SNAP WOUND CARE SYSTEM?

The FDA 510(k) record lists Spiracur, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SNAP WOUND CARE SYSTEM?

The FDA product code for SNAP WOUND CARE SYSTEM is OKO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Spiracur, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K113032SNAP WOUND CARE SYSTEMK111393SNAP (R) WOUND CARE SYSTEMK111006CI-SNAP WOUND CARE SYSTEM

Related Devices (Code: OKO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254160VacHeal Negative Pressure Wound Therapy SystemVacHeal, LLCK251156NPsealGuard Medical, Inc.K250708NPsealGuard Medical, Inc.K241522NPseal (20 and 25)Guard Medical, Inc.K240244NPseal (Small, Medium, Large)Guard Medical, Inc.K212971NPsealGuard Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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