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510(k) K962807

AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES by American Surgical Sponges — Product Code HBA

K962807 is an FDA 510(k) premarket notification submitted by American Surgical Sponges for the device "AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES". The FDA issued a decision of Substantially Equivalent on May 2, 1997. The device falls under product code HBA (Neurosurgical Paddie), a Class II device regulated under 21 CFR 882.4700.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1997
Date Received
July 18, 1996
Clearance Type
Traditional
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 for product code HBA

  • K193346 — Codman Surgical Patties & Strips (November 20, 2020)
  • K140369 — MEDLINE NEURO SPONGE (September 26, 2014)
  • K112598 — AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) (June 20, 2013)
  • 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)

FDA data resources