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510(k) K953438

SURGICAL INTEGRATED CAMERA SYSTEM by Envision Medical Corp. — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1995
Date Received
July 21, 1995
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 Envision Medical Corp.

  • K970605 — 3-CCD DIGITAL CAMERA (May 22, 1997)
  • K951971 — XENON LIGHT SOURCE (May 24, 1995)
  • K944707 — ISOLATED CAMERA HEAD (October 7, 1994)
  • K934092 — CAMERA, SURGICAL AND ACCESSORIES (January 7, 1994)

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