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510(k) K971123

STONE EXTRACTOR by Phx Technologies Corp. — Product Code OCZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1997
Date Received
March 27, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Grasping/Cutting Instrument, Non-Powered
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.

Other clearances by Phx Technologies Corp.

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  • K954507 — RETROGRADE KNIFE (November 14, 1995)
  • K954510 — RRIANGLE KNIFE (November 14, 1995)
  • K954476 — PROBE (October 23, 1995)
  • K954475 — BLUNT DISSECTOR, CURVED (October 23, 1995)
  • K954459 — CONICAL OBTURATOR (October 23, 1995)
  • K954458 — BOAT NOSE OBTURATOR (October 23, 1995)
  • K954463 — DISSECTING OBTURATOR (October 23, 1995)

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  • K133736 — ENDOSCOPIC SUTURE CUTTER (January 7, 2014)
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  • K101298 — ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE (August 5, 2010)
  • K072684 — MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM (January 4, 2008)