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510(k) K790389

GAUZE & COTTON SPONGES by Medtech Intl., Inc. — Product Code GDY

K790389 is an FDA 510(k) premarket notification submitted by Medtech Intl., Inc. for the device "GAUZE & COTTON SPONGES". The FDA issued a decision of Substantially Equivalent on March 26, 1979. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Medtech Intl., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1979
Date Received
February 26, 1979
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 Medtech Intl., Inc.

  • K920876 — CUT RESISTANT GLOVES OR SURGICAL GLOVE LINER (December 11, 1992)
  • K853843 — IV MATE (January 9, 1986)
  • K791462 — HYPERDERMIC NEEDLE WITH SENSOR #514 (September 24, 1979)
  • K790467 — SURGICAL EYE SPONGE (March 26, 1979)
  • K781157 — STIMULATOR, NERVE, TRANSCUTANEOUS (September 20, 1978)

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