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FDA 510(k)

SELF RETAINING SOFT TISSUE RETRACTOR

K-Number: K101609 · 2010-12-09

ApplicantKoros USA, Inc.
Decision Date2010-12-09
Product CodeLXH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SELF RETAINING SOFT TISSUE RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Koros USA, Inc.. It received FDA 510(k) clearance on 2010-12-09 under 510(k) number K101609. The device is classified under product code LXH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SELF RETAINING SOFT TISSUE RETRACTOR?

SELF RETAINING SOFT TISSUE RETRACTOR is a medical device that received FDA 510(k) clearance on 2010-12-09. The listed applicant is Koros USA, Inc.. The 510(k) number is K101609.

When did SELF RETAINING SOFT TISSUE RETRACTOR receive FDA 510(k) clearance?

SELF RETAINING SOFT TISSUE RETRACTOR received FDA 510(k) clearance on 2010-12-09, under 510(k) number K101609.

Who is the listed applicant for SELF RETAINING SOFT TISSUE RETRACTOR?

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

What is the FDA product code for SELF RETAINING SOFT TISSUE RETRACTOR?

The FDA product code for SELF RETAINING SOFT TISSUE RETRACTOR is LXH.

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Other records listing Koros USA, 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.

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Related Devices (Code: LXH)

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.

K192873SX-One MicroKnifeSonex Health, Inc.K001507MICROPERFORATION INSTRUMENTSmith & Nephew, Inc.K952495ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEMOrthopedic Systems, Inc.K943873ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SYOrthomet, Inc.K944188SPINAL MARKERLeibinger L.P.K941896STEADMAN LIGAMENT GRAFT PASSER AND PROTECTORDepuy, 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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