COTTON NEUROLOGICAL SPONGE— 510(k) K854713

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

1985-11-22

Decision date

1986-03-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Ledyard, CT, US

• K193346 — Codman Surgical Patties & Strips2020-11-20
• K140369 — MEDLINE NEURO SPONGE2014-09-26
• K112598 — AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)2013-06-20
• K121822 — DELICOT2012-09-10
• K073576 — NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES2008-02-22

• K922143 — AMERICAN BURN SHEET1992-08-10
• K904514 — STRUNG TELFA NON-ADHERENT SPONGE1991-03-27
• K902921 — RAYON NEUROLOGICAL SPONGE1990-09-18
• K872810 — STRUNG DENTAL ROLLS1987-12-04
• K872951 — AMERICAN BRAIN RETRACTOR COVER1987-09-16

• Z-1725-2016 — American Surgical Americot Blue 1/2" x 1" Ref Number: 20-05S Product Usage: Neurosurgical and Nonneurosurgical Sponges Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1726-2016 — American Surgical Americot Blue 1/2" x 1.5" Ref Number: 20-06S Product Usage: Neurosurgical and Nonneurosurgical SpongesClass II·Terminated·American Surgical Company·20160331
• Z-1751-2016 — American Surgical Ultracot 30 mm x 90 mm (Glassine) Ref Number: 23-15G 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 K854713.