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510(k) K953830

KENSORB by Kentron Health Care, Inc. — Product Code GDY

K953830 is an FDA 510(k) premarket notification submitted by Kentron Health Care, Inc. for the device "KENSORB". The FDA issued a decision of Substantially Equivalent on October 3, 1995. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Kentron Health Care, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1995
Date Received
August 16, 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 Kentron Health Care, Inc.

  • K030693 — KENTEX DISPOSABLE VAGINAL SPECULUM (August 27, 2003)
  • K971917 — KENTRON'S ISOLATION GOWN (September 19, 1997)
  • K972410 — IMPERVIOUS ISOLATION GOWN (September 19, 1997)
  • K953465 — KENTEMP (December 15, 1995)
  • K953914 — KENTEX (November 6, 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)
  • K953088 — TRIANGULAR SPONGES (September 14, 1995)
  • K953060 — ROSEBUD DISSECTOR (September 14, 1995)
  • K953087 — CHERRY PIT DISSECTOR (September 14, 1995)
  • K953062 — CHERRY DISSECTOR (September 14, 1995)
  • K953059 — KITTNER DISSECTOR (September 14, 1995)
  • K953058 — ROUND STICK SPONGES, FLAT STICK SPONGES (September 14, 1995)

FDA data resources