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510(k) K950372

ULTRACELL ORTHOPEDIC SPONGES by Ultracell Medical Technologies, Inc. — Product Code GDY

K950372 is an FDA 510(k) premarket notification submitted by Ultracell Medical Technologies, Inc. for the device "ULTRACELL ORTHOPEDIC SPONGES". The FDA issued a decision of Substantially Equivalent on April 17, 1995. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Ultracell Medical Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1995
Date Received
January 31, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze/Sponge, Internal, X-Ray Detectable
Device Class
Class I
Regulation Number
878.4450
Review Panel
SU
Submission Type

Other clearances by Ultracell Medical Technologies, Inc.

  • K012196 — ULTRACELL ABSORBENT STICK (August 24, 2001)
  • K972634 — ULTRACELL SUCTION SPONGE (December 17, 1997)
  • K972633 — 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)
  • K950370 — ULTRACELL ORTHOPEDIC SPONGES (April 17, 1995)

Other clearances for product code GDY

  • K972634 — ULTRACELL SUCTION SPONGE (December 17, 1997)
  • K960236 — CPR LAP SPONGES (March 28, 1996)
  • K955599 — STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE (February 22, 1996)
  • K955322 — PROTEC X-RAY DETECTABLE GAUZE SPONGE (December 19, 1995)
  • K953830 — KENSORB (October 3, 1995)
  • K953059 — KITTNER DISSECTOR (September 14, 1995)
  • K953088 — TRIANGULAR SPONGES (September 14, 1995)
  • K953087 — CHERRY PIT DISSECTOR (September 14, 1995)
  • K953060 — ROSEBUD DISSECTOR (September 14, 1995)
  • K953062 — CHERRY DISSECTOR (September 14, 1995)

FDA data resources