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510(k) K960637

5MM ENDOSCOPE by Origin Medsystems, Inc. — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1996
Date Received
February 14, 1996
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 Origin Medsystems, Inc.

  • K992353 — BLUNT TIP TROCAR PORT (July 30, 1999)
  • K981700 — VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEM (May 29, 1998)
  • K972685 — ORIGIN LIGATOR DEVICE (October 1, 1997)
  • K970611 — ORIGIN CARDIAC STABLIZER OCCLUDER (August 19, 1997)
  • K965121 — CANNULA (March 20, 1997)
  • K964171 — VASOVIEW BALLOON DISSECTION SYSTEM (February 14, 1997)
  • K962104 — AIRLIFT BALLOON RETRACTON SYSTEM (September 11, 1996)
  • K962005 — EXTRAHAND BALLOON RETRACTOR (August 12, 1996)
  • K960936 — RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES] (July 24, 1996)
  • K955163 — DISSECTION PROBE (January 24, 1996)

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