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510(k) K023735

LAPMAN LAPAROSCOPE MANIPULATOR SYSTEM AND ACCESSORIES, MODEL 900-001 by Medsys, S.A. — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2003
Date Received
November 7, 2002
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

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 Medsys, S.A.

  • K092897 — LAP LOOP (February 1, 2010)
  • K062968 — LAPMAN LAPAROSCOPE MANIPULATOR AND ACCESSORIES, MODEL 900-200 SERIES (January 3, 2007)
  • K971229 — CAPNOXYGEN MASK (September 23, 1997)

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