510(k) K854714 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable
X-RAY DETECTABLE COTTON BALLS
| Applicant | American Silk Sutures, Inc., Ledyard CT, US |
| Decision | Substantially Equivalent, Dec 17, 1985 |
| Received | Nov 22, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854714
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2024 | American Surgical Company, LLC 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 Open, Classified |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Americot Blue 1/4" x 1/4"
Ref Number: 20-01S
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Americot Blue 1/2" x 1/2"
Ref Number: 20-04S
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Americot Blue 1/2" x 3"
Ref Number: 20-07S
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Americot Blue 1" x 3"
Ref Number: 20-10S
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Americot Blue 3/8" x 3/4"
Ref Number: 20-14S
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Americot Blue 1/8" x 1/8"
Ref Number: 20-19S
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Americot Blue 3/8" x 3/8"
Ref Number: 20-22S
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Americot Blue 3/8" x 2"
Ref Number: 20-26S
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Americot Blue 1/4" x 1.5"
Ref Number: 20-30S
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Americot White 1.5 cm x 5.5 cm
Ref Number: 20-31SW
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Americot Blue 1/2" x 2"
Ref Number: 20-32S
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 5 mm x 8 mm
Ref Number: 23-01
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 5 mm x 8 mm (Glassine)
Ref Number: 23-01G
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 5 mm x 13 mm (Glassine)
Ref Number: 23-02G
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 10 mm x 13 mm (Glassine)
Ref Number: 23-03G
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 15 mm x 20 mm
Ref Number: 23-04
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 15 mm x 20 mm (Glassine)
Ref Number: 23-04G
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 6 mm x 50 mm
Ref Number: 23-06
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 9 mm x 50 mm (Glassine)
Ref Number: 23-07G
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 13 mm x 60 mm
Ref Number: 23-08
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 13 mm x 60 mm (Glassine)
Ref Number: 23-08G
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 20 mm x 60 mm
Ref Number: 23-09
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 20 mm x 60 mm (Glassine)
Ref Number: 23-09G
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 30 mm x 70 mm
Ref Number: 23-10
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 30 mm x 70 mm (Glassine)
Ref Number: 23-10G
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 15 mm x 15 mm (Glassine)
Ref Number: 23-12G
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 70 mm x 10090 mm
Ref Number: 23-24
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Cotton Balls-Strung 1/4"
Ref Number: 30-00
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Cotton Balls-Strung 3/8"
Ref Number: 30-01
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Cotton Balls-Strung 1/2"
Ref Number: 30-02
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Cotton Balls-Strung 3/4"
Ref Number: 30-03
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Cotton Balls-Strung 1"
Ref Number: 30-04
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Cotton Balls-Strung 1.25"
Ref Number: 30-05
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Cotton Balls-Strung 1/8"
Ref Number: 30-07
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Cotton Balls-Non-Strung 3/4"
Ref Number: 31-03
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Cotton Balls-Non-Strung 1/8"
Ref Number: 31-07
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
FRL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.