510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN200016Unknown

EndoRotor Device

Interscope, Inc., Whitinsville MA / Direct, Unknown
FDA source (opens on fda.gov)

DEN200016 is the FDA 510(k) clearance record for EndoRotor Device, a class II device, cleared for Interscope, Inc. on under FDA product code QNE (Endoscopic Pancreatic Debridement Device). FDA's definition for product code QNE reads: "An endoscopic pancreatic debridement device is inserted via an endoscope and placed through a cystogastrostomy fistula into the pancreatic cavity. It is intended for removal of necrotic tissue from a walled off pancreatic necrosis (WOPN)...". FDA records list 4 510(k) clearances for Interscope, Inc., from to . As of , FDA records show no recalls naming DEN200016.

Clearance record

Decision date
Received
(282 days to decision)
Product code
QNE Endoscopic Pancreatic Debridement Device
Regulation
21 CFR 876.4330
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Interscope, Inc. 100 Main St., Suite 108, Whitinsville MA
Third party review
No

Clearances, product code QNE

Trailing 12 months

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

FDA records show no clearances under product code QNE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QNE, 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