Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1221144

FEI Number

1221144

Entity Name

AMERICAN SURGICAL COMPANY, LLC

City/State/Country

Beverly, MA, US

Establishment Address

100 Cummings Center, Suite 151-G, Beverly, MA 01915, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

American Surgical Company, LLC (Owner Number: 10030544)

Owner / Operator Contact Address

100 Cummings Center, Suite 151-G, Beverly, MA 01915, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ultracot Sponges Americot Surgical Sponges Ophthalmic Pledget Telfa Sponges Surgical Cotton Balls Uniqcot Delicot Ray-cot Tapered Delicot Comfort Pack

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HBA	Neurosurgical Paddie	Neurology	Class 2	882.4700	2009-10-15
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2018-10-11
HBA	Neurosurgical Paddie	Neurology	Class 2	882.4700	2009-10-26
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2009-11-10
HBA	Neurosurgical Paddie	Neurology	Class 2	882.4700	2009-10-26
OJK	Eye Tray	Ophthalmic	Class 2	886.4790	2018-03-20

Official Correspondent

Erik Piasio

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

American Surgical Company, 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
K842601	Ophthalmic Resources, Inc.	PRE-OPERATIVE OPHTHALMIC DRESSING TRAY	1985-05-10
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0490-2025	Alcon Research LLC	2	a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61 each containing TUBING, SALEM SUMP, 18 FR; d) VITRECTOMY MCGEE EYE SURG CTR, # 12216-12, # 12216-14, and # 12216-15, each containing TUBING, SALEM SUMP, 14 FR.

Similar Registrations

Registration Number	Establishment Name	Location
1055789	WATAUGA OPPORTUNITIES, INC.	BOONE, NC, US
3003418325	Integra LifeSciences Corporation	Princeton, NJ, US
2244478	LYNX Medical NJ	Franklin, NJ, US
1054241	DeRoyal Industries, Inc.	NEW TAZEWELL, TN, US
3012494290	SANICURE BV	SCHIPHOL Noord-Holland, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1221144. Last updated year: 2026. Please use registration number 1221144 when referencing this establishment in official correspondence.