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510(k) K944292

SURGICAL INNOVATIONS DISPOSABLE ENDOSCOPIC HERNIA SURGICAL STAPLER SURGICAL INNOVATIONS RESUABLE SURGICAL STAPLER HANDLE by Surgical Innovations Corp. — Product Code OCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1994
Date Received
September 2, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Tissue Approximation Device
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.

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  • K063485 — LOGIC LAPAROSCOPIC SCISSORS (December 1, 2006)
  • K955393 — NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE (January 9, 1997)
  • K962193 — PORTLAND TROCARS (August 28, 1996)
  • K934105 — DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES (March 28, 1994)
  • K914098 — LAPAROSCOPIC MINI-DISSECTOR/RIGHT ANGLE RETRACTOR (October 28, 1991)

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