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510(k) K112598

AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) by American Surgical Company, LLC — Product Code HBA

K112598 is an FDA 510(k) premarket notification submitted by American Surgical Company, LLC for the device "AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)". The FDA issued a decision of Substantially Equivalent on June 20, 2013. The device falls under product code HBA (Neurosurgical Paddie), a Class II device regulated under 21 CFR 882.4700. American Surgical Company, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2013
Date Received
September 7, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurosurgical Paddie
Device Class
Class II
Regulation Number
882.4700
Review Panel
NE
Submission Type

Other clearances by American Surgical Company, LLC

  • K121822 — DELICOT (September 10, 2012)

Other clearances for product code HBA

  • K193346 — Codman Surgical Patties & Strips (November 20, 2020)
  • K140369 — MEDLINE NEURO SPONGE (September 26, 2014)
  • K121822 — DELICOT (September 10, 2012)
  • K073576 — NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES (February 22, 2008)
  • K062406 — AESCULAP NEURO PATTIES (September 15, 2006)
  • K031008 — AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE) (May 9, 2003)
  • K020736 — TRAATEK COTTONOID PATTIES (June 3, 2002)
  • K014268 — NORAPAD PLAIN; NORAPAD TA (March 27, 2002)
  • K993019 — PACIFIC SURGICAL PATTIES (March 30, 2000)
  • K973083 — ULTRACELL NEURO SPONGES (December 9, 1997)

FDA data resources