Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1119033

FEI Number

1119033

Entity Name

KONSYL PHARMACEUTICALS, INC.

City/State/Country

Easton, MD, US

Establishment Address

29515 Canvasback Drive, Suite B, Easton, MD 21601, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Konsyl Pharmaceuticals, Inc. (Owner Number: 10027168)

Owner / Operator Contact Address

29515 Canvasback Drive, Easton, MD 21601, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K181750

PMA Number

N/A

All Registered Proprietary Names

Sitzmarks

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2019-02-11

Official Correspondent

Frank Gunsallus

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Konsyl Pharmaceuticals, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1119033. Last updated year: 2026. Please use registration number 1119033 when referencing this establishment in official correspondence.