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510(k) K945866

CYLINDRICAL SPONGE by Lorrex Health Products — Product Code GDY

K945866 is an FDA 510(k) premarket notification submitted by Lorrex Health Products for the device "CYLINDRICAL SPONGE". The FDA issued a decision of Substantially Equivalent on December 28, 1994. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Lorrex Health Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1994
Date Received
December 1, 1994
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 Lorrex Health Products

  • K945553 — ROUND STICK SPONGES, FLAT STICK SPONGES (December 28, 1994)
  • K945606 — TRIANGULAR SPONGES (December 28, 1994)
  • K945333 — KITTNER DISSECTOR (December 28, 1994)
  • K945335 — CHERRY DISSECTOR (December 28, 1994)
  • K945334 — CHERRY PIT DISSECTOR (December 5, 1994)
  • K945336 — PEANUT DISSECTOR (December 5, 1994)
  • K945332 — ROSEBUD DISSECTOR (December 5, 1994)
  • K942824 — LORREX IV SPONGES, STERILE 2'S; LORREX DRAIN SPONGES, STERILE 2'S (August 3, 1994)
  • K942314 — LORREX GAUZE SPONGES SPECIALTY (June 2, 1994)
  • K942366 — LORREX GAUZE SPONGES, X-RAY DETECTABLE (May 27, 1994)

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)
  • K953059 — KITTNER DISSECTOR (September 14, 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)

FDA data resources