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510(k) K940425

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

K940425 is an FDA 510(k) premarket notification submitted by Imagyn Medical, Inc. for the device "IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING". The FDA issued a decision of Substantially Equivalent on August 1, 1994. The device falls under product code MAV (Syringe, Balloon Inflation), a Class II device regulated under 21 CFR 870.1650. Imagyn Medical, Inc. has at least 10 other 510(k) clearances on record.

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)

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)

FDA data resources