Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016615875

FEI Number

3016615875

Entity Name

STYMCO MEDICAL LLC

City/State/Country

Tampa, FL, US

Establishment Address

8176 Woodland Center Blvd, Tampa, FL 33614, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Stymco Medical LLC (Owner Number: 10079884)

Owner / Operator Contact Address

8176 Woodland Center Blvd, Tampa, FL 33614, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Wound Care Supply Ostomy Supply Wound Care Dressing Walker Adhesive Dressing Ostomy bag Wound Care Supply Compression Stockings Compression Stockings

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2023-12-07
FHH	Crusher, Spur, Colostomy	Gastroenterology, Urology	Class 1	876.4730	2020-12-31
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2020-12-31
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2020-12-31
MGO	Closure, Wound, Adhesive	General, Plastic Surgery	Class 1	878.4018	2020-12-31
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2020-12-31
PFP	Silicone Hydrogel For Scar Management	General, Plastic Surgery	Class 1	878.4025	2020-12-31
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	General Hospital	Class 2	880.5780	2020-12-31
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2020-12-31

Official Correspondent

Ana Maria Vargas

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Stymco Medical 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
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016615875. Last updated year: 2026. Please use registration number 3016615875 when referencing this establishment in official correspondence.