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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 the device name listed in this FDA 510(k) record. The listed applicant is Interscope, Inc.. It received FDA 510(k) clearance on 2019-01-03 under 510(k) 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. The listed applicant is Interscope, Inc.. The 510(k) number is K181127.

When did EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control receive FDA 510(k) clearance?

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

Who is the listed applicant for EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control?

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

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.

Other records listing Interscope, 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.

K190715EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll StandK170120EndoRotor

Related Devices (Code: PTE)

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.

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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