510(k) K854713 ยท HBA Neurosurgical Paddie
COTTON NEUROLOGICAL SPONGE
| Applicant | American Silk Sutures, Inc., Ledyard CT, US |
| Decision | Substantially Equivalent, Mar 20, 1986 |
| Received | Nov 22, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854713
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2016 | American Surgical Company American Surgical Americot Blue 1/2" x 1"
Ref Number: 20-05S
Product Usage:
Neurosurgical and Nonneurosurgical Sponges
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Americot Blue 1/2" x 1.5"
Ref Number: 20-06S
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 30 mm x 90 mm (Glassine)
Ref Number: 23-15G
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.