EndoRotor

FDA 510(k) K170120 · Interscope, Inc.

Substantially Equivalent

510(k) numberK170120

Submission

Device name
EndoRotor
Applicant
Interscope, Inc.
Worchester, MA, US
Received
January 13, 2017
Decision date
April 18, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PTE – Endoscopic Morcellator Gastroenterology
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1690
Specialty
Obstetrics/Gynecology

For use in endoscopic procedures by a trained gastroenterologist to resect and remove residual tissue from the peripheral margins following EMR (Endoscopic Mucosal Resection)

Other 510(k)s with product code PTE

510(k)DeviceApplicantDecision
K181127EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set…PTE · Traditional Interscope, Inc.01/03/2019SE

More from Interscope, Inc.

510(k)DeviceDecision
K190715EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set…ERL · Traditional 12/13/2019SE
K181127EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set…PTE · Traditional 01/03/2019SE

Questions and answers

When was EndoRotor cleared by the FDA?

EndoRotor (K170120) received a 510(k) decision of Substantially Equivalent on April 18, 2017, 95 days after the submission was received.

What is the product code of K170120?

The FDA product code is PTE – Endoscopic Morcellator Gastroenterology, a Class II (moderate risk) device regulated under 21 CFR 884.1690.