RAYON NEUROLOGICAL SPONGE— 510(k) K902921

Clearance details

Applicant

American Silk Sutures, Inc.

Product code

Code HBA

Device class

Class 2

Regulation

21 CFR 882.4700

Advisory panel

Neurology

Date received

1990-07-03

Decision date

1990-09-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Lynn, MA, US

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• K904514 — STRUNG TELFA NON-ADHERENT SPONGE1991-03-27
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• K872951 — AMERICAN BRAIN RETRACTOR COVER1987-09-16
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• Z-1765-2016 — American Surgical Ray-Cot 1/4" x 3" Ref Number: 60-04 Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1767-2016 — American Surgical Ray-Cot 1/2" x 1" Ref Number: 60-07 Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1768-2016 — American Surgical Ray-Cot 1/2" x 1.5" Ref Number: 60-08 Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1770-2016 — American Surgical Ray-Cot 1" x 1" Ref Number: 60-12 Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1771-2016 — American Surgical Ray-Cot 1" x 3" Ref Number: 60-13 Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1772-2016 — American Surgical Ray-Cot 3" x 3" Ref Number: 60-15 Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1774-2016 — American Surgical Ray-Cot 1/2" x 2" Ref Number: 60-29 Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1794-2016 — American Surgical Uniqcot 1/4" x 1/4" Ref Number: 67-02 Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1795-2016 — American Surgical Uniqcot 1/2" x 1/2" Ref Number: 67-06 Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1796-2016 — American Surgical Uniqcot 1/2" x 1.5" Ref Number: 67-08 Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1797-2016 — American Surgical Uniqcot 1/2" x 3" Ref Number: 67-09 Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1798-2016 — American Surgical Uniqcot 1/2" x 2" Ref Number: 67-29 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 K902921.