510(k) K904514 ยท HBA Neurosurgical Paddie
STRUNG TELFA NON-ADHERENT SPONGE
| Applicant | American Silk Sutures, Inc., Tamarac FL, US |
| Decision | Substantially Equivalent, Mar 27, 1991 |
| Received | Oct 2, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904514
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2016 | American Surgical Company American Surgical Telfa 3/8" x 3"
Ref Number: 80-05
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Telfa 1/2" x 1/2"
Ref Number: 80-06
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Telfa 1/2" x 1.5"
Ref Number: 80-08
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Telfa 1/2" x 3"
Ref Number: 80-09
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Telfa 3/4" x 3"
Ref Number: 80-11
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Telfa 1" x 1"
Ref Number: 80-12
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Telfa 1" x 3"
Ref Number: 80-13
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.