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510(k) K014268

NORAPAD PLAIN; NORAPAD TA by Perlei Medical, Inc. — Product Code HBA

K014268 is an FDA 510(k) premarket notification submitted by Perlei Medical, Inc. for the device "NORAPAD PLAIN; NORAPAD TA". The FDA issued a decision of Substantially Equivalent on March 27, 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
March 27, 2002
Date Received
December 27, 2001
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)
  • K993019 — PACIFIC SURGICAL PATTIES (March 30, 2000)
  • K973083 — ULTRACELL NEURO SPONGES (December 9, 1997)

FDA data resources