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510(k) K882708

GAUZE SPONGE, X-RAY DETECTABLE by Bioseal — Product Code GDY

K882708 is an FDA 510(k) premarket notification submitted by Bioseal for the device "GAUZE SPONGE, X-RAY DETECTABLE". The FDA issued a decision of Substantially Equivalent on August 3, 1988. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Bioseal has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1988
Date Received
June 27, 1988
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 Bioseal

  • K893814 — SURGICAL INSTRUMENT KIT, DISPOSABLE (August 10, 1989)
  • K882695 — RUBBER BAND, STERILE (October 13, 1988)
  • K882696 — DERMICEL, MONTGOMERY STRAP (August 26, 1988)
  • K882694 — FIXATION DEVICE, TRACH TUBE (August 15, 1988)
  • K882712 — STICK SPONGE (August 3, 1988)
  • K882707 — GAUZE PACKING, X-RAY DETECTABLE (August 3, 1988)
  • K882710 — INTESTINAL SPONGES (August 3, 1988)
  • K882709 — TONSIL SPONGE, X-RAY DETECTABLE, W/STRING (August 3, 1988)
  • K882711 — GAUZE SPONGE 12PLY (August 3, 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)
  • K953062 — CHERRY DISSECTOR (September 14, 1995)
  • K953060 — ROSEBUD DISSECTOR (September 14, 1995)
  • K953087 — CHERRY PIT DISSECTOR (September 14, 1995)
  • K953088 — TRIANGULAR SPONGES (September 14, 1995)
  • K953059 — KITTNER DISSECTOR (September 14, 1995)

FDA data resources