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510(k) K831913

COLOR-EZE PRE-WASHED LAP SPONGES by Ormed Mfg., Inc. — Product Code GDY

K831913 is an FDA 510(k) premarket notification submitted by Ormed Mfg., Inc. for the device "COLOR-EZE PRE-WASHED LAP SPONGES". The FDA issued a decision of Substantially Equivalent on September 26, 1983. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Ormed Mfg., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1983
Date Received
June 14, 1983
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 Ormed Mfg., Inc.

  • K931555 — ARTROMOT K2 CPM (January 31, 1994)
  • K882527 — GAUZE SPONGE (July 18, 1988)
  • K882530 — TAPE STRUNG TONSIL SPONGE (July 18, 1988)
  • K882529 — BUTCHER STRUNG TONSIL SPONGE (July 18, 1988)
  • K882528 — CYLINDRICAL SPONGE (July 18, 1988)
  • K880909 — TRACHEOTOMY SPONGES (March 17, 1988)
  • K880852 — ROSEBUD DISSECTORS (March 17, 1988)
  • K880907 — TRIANGLE SPONGE (March 17, 1988)
  • K880853 — CHERRY SPONGE (March 17, 1988)
  • K880851 — FLAT STICK SPONGE (March 17, 1988)

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