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FDA 510(k)

PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301

K-Number: K123110 · 2013-01-17

ApplicantSurgical Innovations Plc
Decision Date2013-01-17
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301 is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Innovations Plc. It received FDA 510(k) clearance on 2013-01-17 under 510(k) number K123110. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301?

PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301 is a medical device that received FDA 510(k) clearance on 2013-01-17. The listed applicant is Surgical Innovations Plc. The 510(k) number is K123110.

When did PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301 receive FDA 510(k) clearance?

PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301 received FDA 510(k) clearance on 2013-01-17, under 510(k) number K123110.

Who is the listed applicant for PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301?

The FDA 510(k) record lists Surgical Innovations Plc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301?

The FDA product code for PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301 is GCJ.

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Other records listing Surgical Innovations Plc as applicant

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Related Devices (Code: GCJ)

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Official Source

View on FDA Database →

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

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