Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015528095

FEI Number

3015528095

Entity Name

CARE SURGICAL LLC

City/State/Country

Hudson, MA, US

Establishment Address

43 Broad St, Suite B106, Hudson, MA 01749, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Care Surgical LLC (Owner Number: 10060214)

Owner / Operator Contact Address

43 Broad St, Suite B106, Hudson, MA 01749, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CS Leg Support Drape & MF Large Dome Pelvic Drape & MF Large CS Pro-Axis Compatible Set CS Jackson Standard Covers CS Single Use Covers CS Dome Chest Drape & MF Large CS Torso Support Medium Drape & MF CS Wingset Comfort Covers CS Comfort Covers CS Bow & Wilson Standard Covers CS Torso Support Medium Drape CS Easy Prone Disposable Cover CS Jackson Comfort Covers CS Table Extention CS Clamps CS FlexiFin Max Stirrups - Hook & Loop CS FlexiFin Stirrups CS FlexiFinless Stirrups CS FlexiFinless Stirrups - Hook and Loop CS FlexiFin Stirrups - Hook & Loop CS FlexiFin Max Stirrups CS Mirror Strip CS Mirror Strip Small

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2022-12-29
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2022-12-29
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2022-12-29
EYD	Stirrups	Gastroenterology, Urology	Class 1	876.4890	2026-03-25
FTX	Mirror, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-08-19

Official Correspondent

Michael Dearnley-Davison

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Care Surgical LLC

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015528095. Last updated year: 2026. Please use registration number 3015528095 when referencing this establishment in official correspondence.