510(k) K121822 ยท HBA Neurosurgical Paddie
DELICOT
| Applicant | American Surgical Company, LLC, Lynn MA, US |
| Decision | Substantially Equivalent, Sep 10, 2012 |
| Received | Jun 21, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121822
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2016 | American Surgical Company American Surgical Delicot 15mm x 20mm
Ref: 63-04
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot 30mm x 70mm
Ref: 63-10
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot 5 mm x 8 mm
Ref Number: 63-01
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot non-xray 5 mm x 8 mm
Ref Number: 63-01 Non X-Ray
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot-J 5 mm x 8 mm
Ref Number: 63-01J (Japan Only)
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot 5 mm x 13 mm
Ref Number: 63-02
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot non-xray 5 mm x 13 mm
Ref Number: 63-02 non-xray
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot 10 mm x 13 mm
Ref Number: 63-03
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot non-xray 10 mm x 13 mm
Ref Number: 63-03 non-xray
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot 4 mm x 50 mm
Ref Number: 63-05
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot-J 15 mm x 20 mm
Ref Number: 63-04J (Japan Only)
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot 4 mm x 50 mm
Ref Number: 63-05
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot 6 mm x 50 mm
Ref Number: 63-06
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot 9 mm x 50 mm
Ref Number: 63-07
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot 13 mm x 60 mm
Ref Number: 63-08
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot-J 13 mm x 60 mm
Ref Number: 63-08J (Japan only)
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot 20 mm x 60 mm
Ref Number: 63-09
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot 30 mm x 70 mm
Ref Number: 63-10
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot-J 30 mm x 70 mm
Ref Number: 63-10J (Japan Only)
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot X 6 mm x 50 mm
Ref Number: 63x06
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Delicot X 9 mm x 50 mm
Ref Number: 63x07
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.