Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1037577

FEI Number

1037577

Entity Name

ANGIOSYSTEMS, INC.

City/State/Country

DUCKTOWN, TN, US

Establishment Address

7 HOPKINS PL., DUCKTOWN, TN 37326, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ANGIOSYSTEMS, INC. (Owner Number: 1037577)

Owner / Operator Contact Address

7 HOPKINS PL., Ducktown, TN 37326, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K843260

PMA Number

N/A

All Registered Proprietary Names

Tray AngioSystems Tray SorbX AngioSystems SorbX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	1992-11-23
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2007-12-12
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2007-12-12
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2010-06-23
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2007-12-12

Official Correspondent

David Scharoun

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ANGIOSYSTEMS, INC.

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
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1037577. Last updated year: 2026. Please use registration number 1037577 when referencing this establishment in official correspondence.