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510(k) K940425

IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING by Imagyn Medical, Inc. — Product Code MAV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1994
Date Received
January 31, 1994
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 Imagyn Medical, Inc.

  • K972426 — MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH (September 23, 1997)
  • K970750 — MICROSPAN INSEMINATION SYSTEM (May 5, 1997)
  • K971255 — IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER (April 21, 1997)
  • K965055 — IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES (March 6, 1997)
  • K963580 — IMAGYN FALLOPOSCOPY SYSTEM (January 31, 1997)
  • K961688 — MICROSPAN HYSTEROSCOPE (October 15, 1996)
  • K961506 — MICROSPAN HYSTEROSCOPE SHEATH (July 3, 1996)
  • K952032 — IMAGYN HYSTEROSCOPE SHEATHS (October 31, 1995)
  • K951996 — IMAGYN ENDOSCOPE (September 1, 1995)
  • K951974 — IMAGYN ENDOSCOPE SHEATH (August 28, 1995)

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  • 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)