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FDA 510(k)

EndoRotor

K-Number: K170120 · 2017-04-18

ApplicantInterscope, Inc.
Decision Date2017-04-18
Product CodePTE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EndoRotor is a medical device manufactured by Interscope, Inc.. It received FDA 510(k) clearance on 2017-04-18 under approval number K170120. The device is classified under product code PTE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndoRotor?

EndoRotor is a medical device that received FDA 510(k) clearance on 2017-04-18. It is manufactured by Interscope, Inc.. The 510(k) number is K170120.

When was EndoRotor approved by the FDA?

EndoRotor received FDA 510(k) clearance on 2017-04-18, under approval number K170120.

What company makes EndoRotor?

EndoRotor is manufactured by Interscope, Inc..

What is the FDA product code for EndoRotor?

The FDA product code for EndoRotor is PTE.

Other Devices by Interscope, Inc.

K190715EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand K181127EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control DEN200016EndoRotor Device

Related Devices (Code: PTE)

K181127EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot ControlInterscope, Inc.

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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