510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K181127Substantially Equivalent

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

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

K181127 is the FDA 510(k) clearance record for EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control, 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 K181127.

Clearance record

Decision date
Received
(248 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 Main St., Suite 108, Whitinsville 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