Americot
Americot Blue 3/4" x 3/4" Non-Sterile
2manufacturers in China registered for this device type
39catalogue numbers in this listing
2510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Hubei (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Allmed Industrial Limited | Shenzhen | Guangdong | Manufacturer | 42 |
Record
| Listed by | American Surgical Company, LLC, United States |
|---|---|
| FDA product code | HBA |
| Device type | Neurosurgical Paddie |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4700 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K854713 |
| Record published | 2016-06-01 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 20-15S | 20 | In distribution | |
| 21-03 | 20 | In distribution | |
| 20-12S | 20 | In distribution | |
| 20-30S | 20 | In distribution | |
| 20-28S | 20 | In distribution | |
| 20-13S | 20 | In distribution | |
| 20-14S | 20 | In distribution | |
| 20-22S | 20 | In distribution | |
| 21-05 | 20 | In distribution | |
| 20-12SNS | In distribution | ||
| 20-04S | 20 | In distribution | |
| 21-04 | 20 | In distribution | |
| 20-08S | 20 | In distribution | |
| 20-11S | 20 | In distribution | |
| 20-08SNS | In distribution | ||
| 21-02 | 20 | In distribution | |
| 21-08 | 20 | In distribution | |
| 20-25S | 20 | In distribution | |
| 21-07 | 20 | In distribution | |
| 20-10SNS | In distribution | ||
| 20-10S | 20 | In distribution | |
| 20-06SNS | In distribution | ||
| 20-17S | 20 | In distribution | |
| 21-06 | 20 | In distribution | |
| 20-07SNS | In distribution | ||
| 20-09S | 20 | In distribution | |
| 20-07S | 20 | In distribution | |
| 20-51SW | 20 | In distribution | |
| 20-06S | 20 | In distribution | |
| 20-05SNS | In distribution | ||
| 20-32S | 20 | In distribution | |
| 20-04SNS | In distribution | ||
| 20-31SW | 20 | In distribution | |
| 20-01S | 20 | In distribution | |
| 21-01 | 20 | In distribution | |
| 20-27S | 20 | In distribution | |
| 20-05S | 20 | In distribution | |
| 20-26S | 20 | In distribution | |
| 20-19S | 20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OMT LLC | OMT, LLC | 126 |
| Neuray ® | Medtronic Xomed, Inc. | 63 |
| Codman® | Integra LifeSciences Production Corporation | 42 |
| Codman | Cerenovus, Inc. | 41 |
| Spetzler Neuro Patties | OMT, LLC | 35 |
| Merocel | Medtronic Xomed, Inc. | 34 |
| Ray-Cot | American Surgical Company, LLC | 26 |
| Uniqcot | American Surgical Company, LLC | 24 |
| Medline | Medline Industries, Inc. | 19 |
| Zevo™ Anterior Cervical Plate System | Medtronic Sofamor Danek, Inc. | 17 |
| Ultracot | American Surgical Company, LLC | 15 |
| Telfa | American Surgical Company, LLC | 13 |
Showing 12 of 24. All products under Neurosurgical Paddie
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K112598 | 2013-06-20 |
| K121822 | 2012-09-10 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| American Surgical Company, LLC | UDI-DI | 2024-09-18 | Class II | Process control | 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. | 390 units | |
| American Surgical Company, LLC | 510(k) number | 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 35 boxes | 2016-10-21 |
| American Surgical Company, LLC | 510(k) number | 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 78 boxes | 2016-10-21 |
Recalls
38 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 343 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 178 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 4 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 442 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 3 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 21 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 7 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 24 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 99 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 165 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 4 cases | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 351 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 27 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 113 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 38 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 315 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 16 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 409 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 1 box | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 28 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 287 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 338 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 97 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 33 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 15 cases | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 165 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 10 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 3 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 3 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 209 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 689 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 39 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 5 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 7 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 27 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 3 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 449 boxes | 2016-10-21 |
| 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 68 boxes | 2016-10-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.