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510(k) K991228

DCI ENDOSCOPE by Karl Storz Endoscopy — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1999
Date Received
April 12, 1999
Clearance Type
Traditional
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 Karl Storz Endoscopy

  • K043375 — FISCH TITANIUM MIDDLE EAR PROSTHESES (January 24, 2005)
  • K030848 — PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX (June 2, 2003)
  • K030009 — KSEA POWERSHAVER SYSTEM S2 (April 2, 2003)
  • K023924 — AUTOCON II 200 ELECTROSURGICAL GENERATOR (February 21, 2003)
  • K023187 — KSEA SPINOSCOPE (December 2, 2002)
  • K011700 — MODULITH SLK LITHOTRIPTER (August 16, 2002)
  • K021776 — KSEA QUADRO SWITCH (August 15, 2002)
  • K013107 — BIOABSORBABLE INTERFERENCE SCREW MEGAFIX (February 26, 2002)
  • K011841 — KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR (September 10, 2001)
  • K010569 — KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP (April 9, 2001)

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  • K251923 — Medical Shaver System (Morcellator) (YSB-IIIA) (January 29, 2026)
  • K252957 — Pneumo Dissector Hook (January 23, 2026)
  • K254014 — Connected OR Hub with Device and Voice Control; SDC4K Information Management Sys (January 13, 2026)
  • K250927 — KARL STORZ Cholangiography Set (November 22, 2025)
  • K242606 — Nuvis® Wireless HD Camera System (Nuvis-2K) (November 20, 2025)
  • K252442 — Kii Structural Balloon Access System (October 31, 2025)