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510(k) K935993

SURGICAL SPONGE X-RAY DETECTABLE by Mcneil Healthcare, Inc. — Product Code GDY

K935993 is an FDA 510(k) premarket notification submitted by Mcneil Healthcare, Inc. for the device "SURGICAL SPONGE X-RAY DETECTABLE". The FDA issued a decision of Substantially Equivalent on Feb 2, 1994. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Mcneil Healthcare, Inc. has 18 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 2, 1994
Date Received
Dec 13, 1993
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
510(k) Exempt

Other clearances by Mcneil Healthcare, Inc.

  • K935930 — NON ADHERENT DRESSING AND NON ADHERENT DRAIN DRESSING (Feb 3, 1994)
  • K935883 — NEUROLOGICAL SPONGES (Feb 3, 1994)
  • K935910 — X-RAY PACKING SPONGE (Jan 31, 1994)
  • K935934 — NON ADHERANT BURN PADS (Jan 31, 1994)
  • K935882 — TONSIL SPONGES (Jan 31, 1994)
  • K935911 — PACKING SPONGE (Jan 31, 1994)
  • K935881 — SPECIALTY SPONGES (Jan 31, 1994)
  • K935940 — GAUZE SPONGE; DRAIN SPONGE (Jan 14, 1994)
  • K935933 — CUSTOM BURN DRESSING (Jan 14, 1994)
  • K935938 — BANDAGE ROLLS, STRETCH GAUZE ROLLS, TEXTURED GAUZE ROLLS (Jan 14, 1994)

Other clearances for product code GDY

  • K972634 — ULTRACELL SUCTION SPONGE (Dec 17, 1997)
  • K960236 — CPR LAP SPONGES (Mar 28, 1996)
  • K955599 — STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE (Feb 22, 1996)
  • K955322 — PROTEC X-RAY DETECTABLE GAUZE SPONGE (Dec 19, 1995)
  • K953830 — KENSORB (Oct 3, 1995)
  • K953060 — ROSEBUD DISSECTOR (Sep 14, 1995)
  • K953058 — ROUND STICK SPONGES, FLAT STICK SPONGES (Sep 14, 1995)
  • K953059 — KITTNER DISSECTOR (Sep 14, 1995)
  • K953087 — CHERRY PIT DISSECTOR (Sep 14, 1995)
  • K953088 — TRIANGULAR SPONGES (Sep 14, 1995)

FDA data resources

Source: FDA 510(k) database entry for K935993. Report a data issue: hello@regdatalab.com.