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510(k) K133795

SUMMED INFLATION DEVICE KIT by Sunny Medical Device (Shenzhen) Co., Ltd. — Product Code MAV

K133795 is an FDA 510(k) premarket notification submitted by Sunny Medical Device (Shenzhen) Co., Ltd. for the device "SUMMED INFLATION DEVICE KIT". The FDA issued a decision of Substantially Equivalent on December 12, 2014. The device falls under product code MAV (Syringe, Balloon Inflation), a Class II device regulated under 21 CFR 870.1650. Sunny Medical Device (Shenzhen) Co., Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2014
Date Received
December 13, 2013
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 Sunny Medical Device (Shenzhen) Co., Ltd.

  • K191827 — Sunmed Disposable Angio-Closure Pads (March 16, 2020)
  • K160190 — Sunmed Control Syringes (November 10, 2016)
  • K153685 — Sunmed Haemostatic Valves (October 13, 2016)
  • K140356 — SUMMED HIGH PRESSURE LINE (March 20, 2015)
  • K120119 — SUNMED GUIDE WIRE (May 11, 2012)

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)
  • K140745 — ENCORE 26 ADVANTAGE KIT (April 17, 2014)
  • K130566 — BASIXTOUCH (June 19, 2013)
  • K122321 — BASIXCONPAK ANALOG INFLATION SYRINGE (December 19, 2012)

FDA data resources