Data / Medical devices / United States / American Surgical Company, LLC
American Surgical Company, LLC: FDA-registered device maker in Beverly, MA, United States, 4 510(k) clearances
American Surgical Company, LLC is registered with the FDA (registration 1221144) in Beverly, MA, United States. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 27, 1991. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1221144
- Address
- 100 Cummings Center, Suites 151-G, 144-F, and 250-G, Beverly, MA, United States, 01915
- Owner or operator
- American Surgical Company, LLC (10030544)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 15, 2009
- Registered through
- 2026
- Brand names listed
- Americot Surgical Sponges, BioBrush, Comfort Pack, Delicot, Ophthalmic Pledget, Ray-cot, Surgical Cotton Balls, Tapered Delicot and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Eye Tray | OJK | 2 | Manufacturer | accessdata.fda.gov |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Contract manufacturer | accessdata.fda.gov |
| Neurosurgical Paddie | HBA | 2 | Manufacturer | accessdata.fda.gov |
| Sponge, Ophthalmic | HOZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 27, 1991 | K904514 | STRUNG TELFA NON-ADHERENT SPONGE | HBA | Substantially Equivalent | American Silk Sutures, Inc. | accessdata.fda.gov |
| September 18, 1990 | K902921 | RAYON NEUROLOGICAL SPONGE | HBA | Substantially Equivalent | American Silk Sutures, Inc. | accessdata.fda.gov |
| March 20, 1986 | K854713 | COTTON NEUROLOGICAL SPONGE | HBA | Substantially Equivalent | American Silk Sutures, Inc. | accessdata.fda.gov |
| December 17, 1985 | K854714 | X-RAY DETECTABLE COTTON BALLS | GDY | Substantially Equivalent | American Silk Sutures, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 18, 2024 | 95464 | Class II | Ongoing | Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S x inches or 6mm x 6mm) Component: N/A | Product defect where the X-ray detectable barium strip (aka radio-opaque marker) becomes detached from the sponge (pattie). May delay surgical process as the surgeon may require extra time to remove the markers from the surgical field. | accessdata.fda.gov |
| March 31, 2016 | 73734 | Class II | Terminated | American Surgical Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges | Product packaging defective compromising sterility | accessdata.fda.gov |
Compare with other makers
- All makers of Sponge, Ophthalmic
- All makers of Eye Tray
- All makers of Gauze/Sponge, Internal, X-Ray Detectable
- All makers of Neurosurgical Paddie
- All makers of Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Updated November 1, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.