DELICOT— 510(k) K121822

Clearance details

Applicant

American Surgical Company, LLC

Product code

Code HBA

Device class

Class 2

Regulation

21 CFR 882.4700

Advisory panel

Neurology

Date received

2012-06-21

Decision date

2012-09-10

Decision

Substantially Equivalent

Clearance type

Special

Location

Lynn, MA, US

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• Z-1721-2016 — American Surgical Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1722-2016 — American Surgical Delicot 30mm x 70mm Ref: 63-10 Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1775-2016 — American Surgical Delicot 5 mm x 8 mm Ref Number: 63-01 Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1776-2016 — American Surgical Delicot non-xray 5 mm x 8 mm Ref Number: 63-01 Non X-Ray Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1777-2016 — American Surgical Delicot-J 5 mm x 8 mm Ref Number: 63-01J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1778-2016 — American Surgical Delicot 5 mm x 13 mm Ref Number: 63-02 Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1779-2016 — American Surgical Delicot non-xray 5 mm x 13 mm Ref Number: 63-02 non-xray Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1780-2016 — American Surgical Delicot 10 mm x 13 mm Ref Number: 63-03 Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1781-2016 — American Surgical Delicot non-xray 10 mm x 13 mm Ref Number: 63-03 non-xray Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1782-2016 — American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1783-2016 — American Surgical Delicot-J 15 mm x 20 mm Ref Number: 63-04J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1784-2016 — American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1785-2016 — American Surgical Delicot 6 mm x 50 mm Ref Number: 63-06 Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1786-2016 — American Surgical Delicot 9 mm x 50 mm Ref Number: 63-07 Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1787-2016 — American Surgical Delicot 13 mm x 60 mm Ref Number: 63-08 Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1788-2016 — American Surgical Delicot-J 13 mm x 60 mm Ref Number: 63-08J (Japan only) Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1789-2016 — American Surgical Delicot 20 mm x 60 mm Ref Number: 63-09 Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1790-2016 — American Surgical Delicot 30 mm x 70 mm Ref Number: 63-10 Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1791-2016 — American Surgical Delicot-J 30 mm x 70 mm Ref Number: 63-10J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1792-2016 — American Surgical Delicot X 6 mm x 50 mm Ref Number: 63x06 Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121822.