Home / 510(k) Clearances / K993019

510(k) K993019

PACIFIC SURGICAL PATTIES by V. Mueller Neuro/Spine — Product Code HBA

K993019 is an FDA 510(k) premarket notification submitted by V. Mueller Neuro/Spine for the device "PACIFIC SURGICAL PATTIES". The FDA issued a decision of Substantially Equivalent on March 30, 2000. The device falls under product code HBA (Neurosurgical Paddie), a Class II device regulated under 21 CFR 882.4700. V. Mueller Neuro/Spine has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2000
Date Received
September 8, 1999
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 V. Mueller Neuro/Spine

  • K002276 — PSI SKULL CLAMP (August 29, 2000)
  • K991959 — PSI TITANIUM ANEURYSM CLIP (January 6, 2000)
  • K991002 — PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP (June 11, 1999)
  • K972750 — TAKA ANEURYSM CLIP (July 9, 1998)
  • K964402 — VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM (January 23, 1997)
  • K942601 — PSI FLEXIBLE ARM (December 27, 1994)
  • K943635 — ULTRA-LINE RONGEUR (December 7, 1994)

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)
  • K973083 — ULTRACELL NEURO SPONGES (December 9, 1997)

FDA data resources