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FDA 510(k)

SINGHMED ROOLIP MANIPULATOR

K-Number: K110819 · 2011-10-05

ApplicantJ.Singh Instruments
Decision Date2011-10-05
Product CodeHEW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SINGHMED ROOLIP MANIPULATOR is the device name listed in this FDA 510(k) record. The listed applicant is J.Singh Instruments. It received FDA 510(k) clearance on 2011-10-05 under 510(k) number K110819. The device is classified under product code HEW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGHMED ROOLIP MANIPULATOR?

SINGHMED ROOLIP MANIPULATOR is a medical device that received FDA 510(k) clearance on 2011-10-05. The listed applicant is J.Singh Instruments. The 510(k) number is K110819.

When did SINGHMED ROOLIP MANIPULATOR receive FDA 510(k) clearance?

SINGHMED ROOLIP MANIPULATOR received FDA 510(k) clearance on 2011-10-05, under 510(k) number K110819.

Who is the listed applicant for SINGHMED ROOLIP MANIPULATOR?

The FDA 510(k) record lists J.Singh Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINGHMED ROOLIP MANIPULATOR?

The FDA product code for SINGHMED ROOLIP MANIPULATOR is HEW.

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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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