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510(k) K960236

CPR LAP SPONGES by Custom Pack Reliability — Product Code GDY

K960236 is an FDA 510(k) premarket notification submitted by Custom Pack Reliability for the device "CPR LAP SPONGES". The FDA issued a decision of Substantially Equivalent on March 28, 1996. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Custom Pack Reliability has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1996
Date Received
January 16, 1996
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 Custom Pack Reliability

  • K960205 — CPR TRACHEOTOMY CARE TRAY (August 27, 1996)
  • K960243 — CPR C-SECTION DELIVERY PACK (May 23, 1996)
  • K960239 — CPR D & C TRAY (May 23, 1996)
  • K960216 — CPR SUCTION CATHETER KIT (April 15, 1996)
  • K960210 — CPR ORTHO HAND PACK (April 12, 1996)
  • K960211 — CPR TOTAL KNEE PACK (April 12, 1996)
  • K960213 — CPR TOTAL HIP PACK (April 12, 1996)
  • K960206 — CPR DRESSING CHANGE TRAY (April 12, 1996)
  • K960209 — CPR HEART PACK (April 4, 1996)
  • K960212 — CPR IRRIGATION TRAY (April 1, 1996)

Other clearances for product code GDY

  • K972634 — ULTRACELL SUCTION SPONGE (December 17, 1997)
  • 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)
  • K953058 — ROUND STICK SPONGES, FLAT STICK SPONGES (September 14, 1995)
  • K953059 — KITTNER DISSECTOR (September 14, 1995)
  • K953087 — CHERRY PIT DISSECTOR (September 14, 1995)
  • K953062 — CHERRY DISSECTOR (September 14, 1995)

FDA data resources