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510(k) K971374

GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE by Wilson Greatbatch Technologies, Inc. — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1998
Date Received
April 14, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type

Other clearances by Wilson Greatbatch Technologies, Inc.

  • K971377 — GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE (April 30, 1998)
  • K972280 — GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES (December 11, 1997)
  • K971781 — GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES (November 21, 1997)
  • K970619 — GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE (November 19, 1997)
  • K971375 — GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE (October 31, 1997)
  • K954649 — WGL ENDOSCOPIC GRASPER W/DETACHABLE STRAP (December 22, 1995)
  • K950063 — WGL ENDOSCOPIC GRASPER* (January 27, 1995)
  • K942168 — WGL ENDOSCOPIC GRASPER (December 13, 1994)

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