Home / 510(k) Clearances / K920353

510(k) K920353

ULTRACELL INSTRUMENT WIPE by Ultracell Medical Technologies, Inc. — Product Code HEP

K920353 is an FDA 510(k) premarket notification submitted by Ultracell Medical Technologies, Inc. for the device "ULTRACELL INSTRUMENT WIPE". The FDA issued a decision of Substantially Equivalent on September 15, 1992. The device falls under product code HEP (Monitor, Blood-Flow, Ultrasonic), a Class II device regulated under 21 CFR 884.2660. Ultracell Medical Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1992
Date Received
January 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Blood-Flow, Ultrasonic
Device Class
Class II
Regulation Number
884.2660
Review Panel
OB
Submission Type

Other clearances by Ultracell Medical Technologies, Inc.

  • K012196 — ULTRACELL ABSORBENT STICK (August 24, 2001)
  • K972633 — ULTRACELL SUCTION SPONGE (December 17, 1997)
  • K972634 — ULTRACELL SUCTION SPONGE (December 17, 1997)
  • K973083 — ULTRACELL NEURO SPONGES (December 9, 1997)
  • K973558 — VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) (November 24, 1997)
  • K973085 — ULTRACELL PACKING WITH SLEEVE (November 18, 1997)
  • K972635 — ULTRACELL SUCTION SPONGE (October 1, 1997)
  • K970328 — ULTRACELL NEURO SPONGES (April 21, 1997)
  • K950647 — ULTRACELL NEURO SPONGES (August 15, 1995)
  • K950373 — ULTRACELL ORTHOPEDIC SPONGES (April 17, 1995)

Other clearances for product code HEP

  • K101960 — SONOTRAX SERIES ULTRASONIC POCKET DOPPLER (August 10, 2010)
  • K023082 — BABYCARE (March 3, 2003)
  • K910462 — POCKET DOP 3 (June 24, 1991)

FDA data resources