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510(k) K012771

TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX by Pajunk GmbH — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2001
Date Received
August 17, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Laparoscope, General & Plastic Surgery
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Pajunk GmbH

  • K113207 — SONO TAP, TUOHY SONO (February 29, 2012)
  • K113209 — CHIBA SONO (November 21, 2011)
  • 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)

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