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FDA 510(k)

EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control

K-Number: K181127 · 2019-01-03

ApplicantInterscope, Inc.
Decision Date2019-01-03
Product CodePTE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control is a medical device manufactured by Interscope, Inc.. It received FDA 510(k) clearance on 2019-01-03 under approval number K181127. 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 Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control?

EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control is a medical device that received FDA 510(k) clearance on 2019-01-03. It is manufactured by Interscope, Inc.. The 510(k) number is K181127.

When was EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control approved by the FDA?

EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control received FDA 510(k) clearance on 2019-01-03, under approval number K181127.

What company makes EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control?

EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control is manufactured by Interscope, Inc..

What is the FDA product code for EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control?

The FDA product code for EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control is PTE.

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Other Devices by Interscope, Inc.

K170120EndoRotor K190715EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand DEN200016EndoRotor Device

Related Devices (Code: PTE)

K170120EndoRotorInterscope, 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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