Company ยท US
American Surgical Company
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2013. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
92recalls (0 in 12 months)
86recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 20, 2013 | K112598 | AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) American Surgical Company, LLC | HBA |
| Sep 10, 2012 | K121822 | DELICOT American Surgical Company, LLC | HBA |
| Feb 7, 1986 | K834162 | VIT PAC American Surgical Co., Inc. | HQE |
| Feb 7, 1986 | K834160 | VITREONIC PLUS American Surgical Co., Inc. | HQE |
| Oct 5, 1984 | K841738 | AMER. SURGICAL CORP. EXTRA PLUS PAK American Surgical Co., Inc. | HQE |
| Dec 28, 1983 | K834163 | ULTRAVIT American Surgical Co., Inc. | HQE |
| Dec 28, 1983 | K834161 | UNIVERSAL PAC American Surgical Co., Inc. | HQC |
| Dec 28, 1983 | K834159 | PHACOTRON PLUS American Surgical Co., Inc. | HQC |
| Dec 28, 1983 | K834158 | EXTRA SENSORY PLUS American Surgical Co., Inc. | HQC |
| Dec 28, 1983 | K833697 | EXTRA SENSORY PAK-DISPOS. ACCESS American Surgical Co., Inc. | HQC |
| Dec 28, 1983 | K833617 | EXTRA PLUS TM American Surgical Co., Inc. | HQC |
Latest recalls
| 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 | K854714 |
| Mar 31, 2016 | American Surgical Company Mass Eye & Ear Finger Cot Nasal 2's
Ref Number: 41-04
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
LZB | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Policot 1/2" x 2"
Ref Number: 90-29
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
K862494 | |
| Mar 31, 2016 | American Surgical Company American Surgical Policot 1/2" x 1.5"
Ref Number: 90-08
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K862494 |
| Mar 31, 2016 | American Surgical Company American Surgical Policot 1/2" x 1/2"
Ref Number: 90-06
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K862494 |
| Mar 31, 2016 | American Surgical Company American Surgical Policot 1/4" x 1/4"
Ref Number: 90-02
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K862494 |
| Mar 31, 2016 | American Surgical Company American Surgical Telfa 1" x 3"
Ref Number: 80-13
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K904514 |
| Mar 31, 2016 | American Surgical Company American Surgical Telfa 1" x 1"
Ref Number: 80-12
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K904514 |
| 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 | K904514 |
| 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 | K904514 |
| 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 | K904514 |
| 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 | K904514 |
| 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 | K904514 |
| Mar 31, 2016 | American Surgical Company American Surgical Cylindrical Sponges-Strung 1/2" x 1.5"
Ref Number: 70-02
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
EFN | K872810 |
| Mar 31, 2016 | American Surgical Company American Surgical Uniqcot 1/2" x 2"
Ref Number: 67-29
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K902921 |
| Mar 31, 2016 | American Surgical Company American Surgical Uniqcot 1/2" x 3"
Ref Number: 67-09
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K902921 |
| Mar 31, 2016 | American Surgical Company American Surgical Uniqcot 1/2" x 1.5"
Ref Number: 67-08
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K902921 |
| Mar 31, 2016 | American Surgical Company American Surgical Uniqcot 1/2" x 1/2"
Ref Number: 67-06
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K902921 |
| Mar 31, 2016 | American Surgical Company American Surgical Uniqcot 1/4" x 1/4"
Ref Number: 67-02
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K902921 |
| 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 | K121822 |
| 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 | K121822 |
| 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 | K121822 |
| 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 | K121822 |
| 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 | K121822 |
| 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 | K121822 |
| 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 | K121822 |
| 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 | K121822 |
| 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 | K121822 |
| 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 | K121822 |
| 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 | K121822 |
| 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 | K121822 |
| 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 | K121822 |
| 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 | K121822 |
| 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 | K121822 |
| 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 | K121822 |
| 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 | K121822 |
| 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 | K121822 |
| 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 | K121822 |
| Mar 31, 2016 | American Surgical Company American Surgical Ray-Cot 1/2" x 2"
Ref Number: 60-29
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K902921 |
| Mar 31, 2016 | American Surgical Company American Surgical Ray-Cot 1.5" x 3"
Ref Number: 60-22
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Ray-Cot 3" x 3"
Ref Number: 60-15
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K902921 |
| Mar 31, 2016 | American Surgical Company American Surgical Ray-Cot 1" x 3"
Ref Number: 60-13
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K902921 |
| Mar 31, 2016 | American Surgical Company American Surgical Ray-Cot 1" x 1"
Ref Number: 60-12
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K902921 |
| Mar 31, 2016 | American Surgical Company American Surgical Ray-Cot 1/2" x 3"
Ref Number: 60-09
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Ray-Cot 1/2" x 1.5"
Ref Number: 60-08
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K902921 |
| Mar 31, 2016 | American Surgical Company American Surgical Ray-Cot 1/2" x 1"
Ref Number: 60-07
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K902921 |
| Mar 31, 2016 | American Surgical Company American Surgical Ray-Cot 1/2" x 1/2"
Ref Number: 60-06
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Ray-Cot 1/4" x 3"
Ref Number: 60-04
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | K902921 |
| Mar 31, 2016 | American Surgical Company American Surgical Ray-Cot 1/4" x 1/4"
Ref Number: 60-02
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
HBA | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Tonsil Sponges 1" Large
Ref Number: 50-01
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
EFQ | K872806 |
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