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510(k) K812707

STERILE DISSECTOR SPONGES-X-RAY DETECT by Medspec Corp. — Product Code GDY

K812707 is an FDA 510(k) premarket notification submitted by Medspec Corp. for the device "STERILE DISSECTOR SPONGES-X-RAY DETECT". The FDA issued a decision of Substantially Equivalent on November 2, 1981. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Medspec Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1981
Date Received
September 24, 1981
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 Medspec Corp.

  • K813012 — STERILE BASIN SETS (November 6, 1981)
  • K812710 — STERILE LAPAROTOMY SPONGES-X-RAY DETECT (November 2, 1981)
  • K812711 — STERILE GAUZE PADS 12PLY (November 2, 1981)
  • K812709 — STERILE DENTAL ROLL (October 23, 1981)
  • K810071 — STERILE SILICONE TUBING (February 12, 1981)
  • K810069 — STERILE AIRWAY (February 2, 1981)
  • K802060 — STERILE TONSIL SPONGES (October 10, 1980)
  • K801069 — STERILE ISOLATION GOWN (May 20, 1980)
  • K801068 — STERILE ABDOMINAL PAD (May 20, 1980)
  • K800278 — MEDSPEC SAFETY PINS (May 2, 1980)

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)
  • K953088 — TRIANGULAR SPONGES (September 14, 1995)
  • K953060 — ROSEBUD DISSECTOR (September 14, 1995)
  • K953087 — CHERRY PIT DISSECTOR (September 14, 1995)
  • K953059 — KITTNER DISSECTOR (September 14, 1995)
  • K953062 — CHERRY DISSECTOR (September 14, 1995)

FDA data resources