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510(k) K770924

GREEN RADIOPAQUE IN SURG. SPONGES by Kendall Research Center — Product Code GDY

K770924 is an FDA 510(k) premarket notification submitted by Kendall Research Center for the device "GREEN RADIOPAQUE IN SURG. SPONGES". The FDA issued a decision of Substantially Equivalent on August 10, 1977. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Kendall Research Center has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1977
Date Received
May 20, 1977
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 Kendall Research Center

  • K802225 — TENDER-SORB DRAIN SPONGES (September 26, 1980)
  • K781357 — T.E.D. SEQUENTIAL COMPRESSION SLEEVES (September 20, 1978)
  • K780408 — MICRONET LIGHT DRESSING SPONGE (March 22, 1978)
  • K780062 — CATHETER/HEMOSTATIC/GERIATRIC (February 14, 1978)
  • K780120 — ANESTHESIA TRAY, CAUDAL (February 6, 1978)
  • K772134 — SYRINGE, IRRIGATION, PRE-FILLED (November 28, 1977)
  • K772133 — URINE SPECIMEN COLLECTING DEVICE (November 28, 1977)
  • K771655 — CURITY PEAKOMETER (October 14, 1977)
  • K771079 — CURITY IRRIGATION TRAY (September 15, 1977)
  • K771452 — CONFORM STRETCH BANDAGE (5SIZES) (September 12, 1977)

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)
  • K953062 — CHERRY DISSECTOR (September 14, 1995)
  • K953059 — KITTNER DISSECTOR (September 14, 1995)

FDA data resources