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510(k) K952566

OSCILFLATOR by Surgical Technologies, Inc. — Product Code MAV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1995
Date Received
June 2, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Balloon Inflation
Device Class
Class II
Regulation Number
870.1650
Review Panel
CV
Submission Type

Other clearances by Surgical Technologies, Inc.

  • K941992 — CYSTOSCOPE (November 30, 1995)
  • K942029 — ARTHROSCOPE (November 8, 1995)
  • K946136 — INFINITECH LIGHTED INFUSION CANNULA (October 2, 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)
  • K941161 — FLEXIBLE GRASPING FORCEPS (May 4, 1994)

Other clearances for product code MAV

  • K220773 — Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Dev (April 13, 2022)
  • K162272 — Fluent inflation device (October 20, 2016)
  • K153038 — Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disp (April 13, 2016)
  • K153672 — basixTOUCH40 Inflation Syringe (January 20, 2016)
  • K152387 — Fluent Inflation Device (December 18, 2015)
  • K140943 — MASTRO PLUS BALLOON IN-DEFLATION DEVICE (March 5, 2015)
  • K143522 — Presto Inflation Device (January 12, 2015)
  • K133795 — SUMMED INFLATION DEVICE KIT (December 12, 2014)
  • K140745 — ENCORE 26 ADVANTAGE KIT (April 17, 2014)
  • K130566 — BASIXTOUCH (June 19, 2013)