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510(k) K844594

NEURO CUSTOM SURGICAL KIT by Xanmed Corp. — Product Code HBA

K844594 is an FDA 510(k) premarket notification submitted by Xanmed Corp. for the device "NEURO CUSTOM SURGICAL KIT". The FDA issued a decision of Substantially Equivalent on June 13, 1985. The device falls under product code HBA (Neurosurgical Paddie), a Class II device regulated under 21 CFR 882.4700. Xanmed Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1985
Date Received
November 26, 1984
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 by Xanmed Corp.

  • K864623 — OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT (January 14, 1987)
  • K844595 — ORTHOPEDIC CUSTOM SURGICAL KIT (August 21, 1985)
  • K844596 — EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KIT (August 1, 1985)
  • K844593 — CARDIOVASCULAR CUSTOM SURGICAL KIT (June 21, 1985)
  • K851906 — SURGICAL EYE PACK (May 21, 1985)
  • K844597 — MISCELLANEOUS GENERAL SURGICAL CUSTOM KIT (April 8, 1985)
  • K843641 — CATHETER INTRODUCER SYSTEM (October 23, 1984)
  • K843642 — SUBCLAVIAN LEAD INTRODUCER SYS (October 23, 1984)

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