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510(k) K020736

TRAATEK COTTONOID PATTIES by Traatek, Inc. — Product Code HBA

K020736 is an FDA 510(k) premarket notification submitted by Traatek, Inc. for the device "TRAATEK COTTONOID PATTIES". The FDA issued a decision of Substantially Equivalent on June 3, 2002. 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
June 3, 2002
Date Received
March 6, 2002
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)
  • 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