American Surgical Company, LLC
Beverly, MA, US
AMERICAN SURGICAL COMPANY, LLC appears in FDA device records in Beverly, MA. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 92 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for American Surgical Company, LLC between 1983 and 2013. The busiest year on record is 1983, with 6. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 6 |
| 1984 | 1 |
| 1986 | 2 |
| 2012 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K112598 | AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) | HBA | Substantially Equivalent | |
| K121822 | DELICOT | HBA | Substantially Equivalent | |
| K834162 | VIT PAC | HQE | Substantially Equivalent | |
| K834160 | VITREONIC PLUS | HQE | Substantially Equivalent | |
| K841738 | AMER. SURGICAL CORP. EXTRA PLUS PAK | HQE | Substantially Equivalent | |
| K834163 | ULTRAVIT | HQE | Substantially Equivalent | |
| K834161 | UNIVERSAL PAC | HQC | Substantially Equivalent | |
| K834159 | PHACOTRON PLUS | HQC | Substantially Equivalent | |
| K834158 | EXTRA SENSORY PLUS | HQC | Substantially Equivalent | |
| K833697 | EXTRA SENSORY PAK-DISPOS. ACCESS | HQC | Substantially Equivalent | |
| K833617 | EXTRA PLUS TM | HQC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1221144 | 1221144 | AMERICAN SURGICAL COMPANY, LLC | 100 Cummings Center, Suites 151-G, 144-F, and 250-G, Beverly, MA 01915 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
Showing 25 of 92| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0287-2025 | 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. | Class II | Open, Classified | |
| Z-1811-2016 | Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges | Product packaging defective compromising sterility | Class II | Terminated | |
| Z-1810-2016 | American Surgical Policot 1/2" x 2" Ref Number: 90-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges | Product packaging defective compromising sterility | Class II | Terminated | |
| Z-1809-2016 | American Surgical Policot 1/2" x 1.5" Ref Number: 90-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges | Product packaging defective compromising sterility | Class II | Terminated | |
| Z-1808-2016 | American Surgical Policot 1/2" x 1/2" Ref Number: 90-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges | Product packaging defective compromising sterility | Class II | Terminated | |
| Z-1807-2016 | American Surgical Policot 1/4" x 1/4" Ref Number: 90-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges | Product packaging defective compromising sterility | Class II | Terminated | |
| Z-1806-2016 | American Surgical Telfa 1" x 3" Ref Number: 80-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges | Product packaging defective compromising sterility | Class II | Terminated | |
| Z-1805-2016 | American Surgical Telfa 1" x 1" Ref Number: 80-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges | Product packaging defective compromising sterility | Class II | Terminated | |
| Z-1804-2016 | American Surgical Telfa 3/4" x 3" Ref Number: 80-11 Product Usage: Neurosurgical and Nonneurosurgical Sponges | Product packaging defective compromising sterility | Class II | Terminated | |
| Z-1803-2016 | American Surgical Telfa 1/2" x 3" Ref Number: 80-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges | Product packaging defective compromising sterility | Class II | Terminated | |
| Z-1802-2016 | American Surgical Telfa 1/2" x 1.5" Ref Number: 80-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges | Product packaging defective compromising sterility | Class II | Terminated | |
| Z-1801-2016 | American Surgical Telfa 1/2" x 1/2" Ref Number: 80-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges | Product packaging defective compromising sterility | Class II | Terminated | |
| Z-1800-2016 | American Surgical Telfa 3/8" x 3" Ref Number: 80-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges | Product packaging defective compromising sterility | Class II | Terminated | |
| Z-1799-2016 | American Surgical Cylindrical Sponges-Strung 1/2" x 1.5" Ref Number: 70-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges | Product packaging defective compromising sterility | Class II | Terminated | |
| Z-1798-2016 | American Surgical Uniqcot 1/2" x 2" Ref Number: 67-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges | Product packaging defective compromising sterility | Class II | Terminated | |
| Z-1797-2016 | American Surgical Uniqcot 1/2" x 3" Ref Number: 67-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges | Product packaging defective compromising sterility | Class II | Terminated | |
| Z-1796-2016 | American Surgical Uniqcot 1/2" x 1.5" Ref Number: 67-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges | Product packaging defective compromising sterility | Class II | Terminated | |
| Z-1795-2016 | American Surgical Uniqcot 1/2" x 1/2" Ref Number: 67-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges | Product packaging defective compromising sterility | Class II | Terminated | |
| Z-1794-2016 | American Surgical Uniqcot 1/4" x 1/4" Ref Number: 67-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges | Product packaging defective compromising sterility | Class II | Terminated | |
| Z-1793-2016 | American Surgical Delicot X 9 mm x 50 mm Ref Number: 63x07 Product Usage: Neurosurgical and Nonneurosurgical Sponges | Product packaging defective compromising sterility | Class II | Terminated | |
| Z-1792-2016 | American Surgical Delicot X 6 mm x 50 mm Ref Number: 63x06 Product Usage: Neurosurgical and Nonneurosurgical Sponges | Product packaging defective compromising sterility | Class II | Terminated | |
| Z-1791-2016 | American Surgical Delicot-J 30 mm x 70 mm Ref Number: 63-10J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges | Product packaging defective compromising sterility | Class II | Terminated | |
| Z-1790-2016 | American Surgical Delicot 30 mm x 70 mm Ref Number: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges | Product packaging defective compromising sterility | Class II | Terminated | |
| Z-1789-2016 | American Surgical Delicot 20 mm x 60 mm Ref Number: 63-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges | Product packaging defective compromising sterility | Class II | Terminated | |
| Z-1788-2016 | American Surgical Delicot-J 13 mm x 60 mm Ref Number: 63-08J (Japan only) Product Usage: Neurosurgical and Nonneurosurgical Sponges | Product packaging defective compromising sterility | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain