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510(k) K950647

ULTRACELL NEURO SPONGES by Ultracell Medical Technologies, Inc. — Product Code HBA

K950647 is an FDA 510(k) premarket notification submitted by Ultracell Medical Technologies, Inc. for the device "ULTRACELL NEURO SPONGES". The FDA issued a decision of Substantially Equivalent on August 15, 1995. The device falls under product code HBA (Neurosurgical Paddie), a Class II device regulated under 21 CFR 882.4700. Ultracell Medical Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1995
Date Received
February 13, 1995
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 Ultracell Medical Technologies, Inc.

  • K012196 — ULTRACELL ABSORBENT STICK (August 24, 2001)
  • K972634 — ULTRACELL SUCTION SPONGE (December 17, 1997)
  • K972633 — ULTRACELL SUCTION SPONGE (December 17, 1997)
  • K973083 — ULTRACELL NEURO SPONGES (December 9, 1997)
  • K973558 — VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) (November 24, 1997)
  • K973085 — ULTRACELL PACKING WITH SLEEVE (November 18, 1997)
  • K972635 — ULTRACELL SUCTION SPONGE (October 1, 1997)
  • K970328 — ULTRACELL NEURO SPONGES (April 21, 1997)
  • K950373 — ULTRACELL ORTHOPEDIC SPONGES (April 17, 1995)
  • K950372 — ULTRACELL ORTHOPEDIC SPONGES (April 17, 1995)

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