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510(k) K113209

CHIBA SONO by Pajunk GmbH — Product Code KNW

K113209 is an FDA 510(k) premarket notification submitted by Pajunk GmbH for the device "CHIBA SONO". The FDA issued a decision of Substantially Equivalent on November 21, 2011. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Pajunk GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2011
Date Received
October 31, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type

Other clearances by Pajunk GmbH

  • K113207 — SONO TAP, TUOHY SONO (February 29, 2012)
  • K060563 — EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV (June 2, 2006)
  • K053283 — UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET (January 12, 2006)
  • K053282 — ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP (December 13, 2005)
  • K043130 — MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS (December 21, 2004)
  • K042979 — MODIFICATION TO: PLEXALONG SETS (December 21, 2004)
  • K040965 — PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES (September 7, 2004)
  • K033018 — STIMULONG PLUS CATHETER SET MODEL, VARIOUS (May 5, 2004)
  • K033249 — PAJUNK MODULAR HANDLE INSTRUMENTS (March 5, 2004)
  • K023218 — MODIFICATION TO PLEXOLONG SETS (March 24, 2003)

Other clearances for product code KNW

  • K260517 — Automatic Core Biopsy Instrument (August 28, 2026)
  • K262571 — EnCor EnCompass™ Breast Biopsy and Tissue Removal System (August 14, 2026)
  • K262792 — Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) (August 12, 2026)
  • K260572 — Marrow Marxman (August 4, 2026)
  • K261196 — Promisemed VeriEcto Automatic Biopsy Needles (May 12, 2026)
  • K260365 — Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Ma (March 4, 2026)
  • K252795 — ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy De (February 23, 2026)
  • K252681 — EnCor EnCompass™ Breast Biopsy and Tissue Removal System (December 12, 2025)
  • K252183 — Resitu Slider 09 (RESL09) (September 24, 2025)
  • K243407 — Forcyte Autograft Harvest Kit (July 29, 2025)

FDA data resources