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510(k) K911699

STI TISSUE MANIPULATOR by Surgical Technologies, Inc. — Product Code HIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1991
Date Received
April 16, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
Device Class
Class II
Regulation Number
884.4150
Review Panel
OB
Submission Type

Other clearances by Surgical Technologies, Inc.

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  • K942029 — ARTHROSCOPE (November 8, 1995)
  • K946136 — INFINITECH LIGHTED INFUSION CANNULA (October 2, 1995)
  • K952566 — OSCILFLATOR (August 31, 1995)
  • K951918 — SURGICAL TECHNOLOGIES, INC. SYRINGE (July 20, 1995)
  • K950683 — ARTHROGRAM TRAY (May 6, 1995)
  • K946135 — INFINITECH ASPIRATING LASER PROBE (April 18, 1995)
  • K946181 — INFINITECH SOFT TIP FLUTE NEEDLE (March 14, 1995)
  • K942030 — BIOPSY SCISSORS (June 27, 1994)
  • K942482 — PRESSURE MONITORING EXTENSION (June 14, 1994)

Other clearances for product code HIN

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  • K122983 — KSEA BIPOLAR ELECTRODE (June 26, 2013)
  • K122605 — PKS BILL (December 5, 2012)
  • K113080 — TUBALGATOR (June 29, 2012)
  • K111751 — VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP E (December 2, 2011)
  • K111059 — GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) (September 1, 2011)
  • K990147 — BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.77 (April 16, 1999)
  • K971565 — BICOAG COAGULATING FORCEPS (March 12, 1998)
  • K926517 — ELMED LBC 50-P (November 15, 1994)