510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K170120Substantially Equivalent

EndoRotor

Interscope, Inc., Worchester MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K170120 is the FDA 510(k) clearance record for EndoRotor, a class II device, cleared for Interscope, Inc. on under FDA product code PTE (Endoscopic Morcellator Gastroenterology). FDA's definition for product code PTE reads: "For use in endoscopic procedures by a trained gastroenterologist to resect and remove residual tissue from the peripheral margins following EMR (Endoscopic Mucosal Resection)". FDA records list 4 510(k) clearances for Interscope, Inc., from to . As of , FDA records show no recalls naming K170120.

Clearance record

Decision date
Received
(95 days to decision)
Product code
PTE Endoscopic Morcellator Gastroenterology
Regulation
21 CFR 884.1690
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Interscope, Inc. 100 Grove St., Suite 108, Worchester MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PTE

Trailing 12 months

FDA records hold no clearances under product code PTE in the trailing twelve months.

FDA records show no clearances under product code PTE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PTE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260