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510(k) K935942

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

K935942 is an FDA 510(k) premarket notification submitted by Mcneil Healthcare, Inc. for the device "SURGICAL LAPAROTOMY SPONGE X-RAY DETECTABLE". The FDA issued a decision of Substantially Equivalent on Jan 13, 1994. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Mcneil Healthcare, Inc. has 18 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 13, 1994
Date Received
Dec 13, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Gauze/Sponge, Internal
Device Class
Class U
Review Panel
SU
Submission Type
510(k)

Other clearances by Mcneil Healthcare, Inc.

  • K935930 — NON ADHERENT DRESSING AND NON ADHERENT DRAIN DRESSING (Feb 3, 1994)
  • K935883 — NEUROLOGICAL SPONGES (Feb 3, 1994)
  • K935993 — SURGICAL SPONGE X-RAY DETECTABLE (Feb 2, 1994)
  • K935934 — NON ADHERANT BURN PADS (Jan 31, 1994)
  • K935882 — TONSIL SPONGES (Jan 31, 1994)
  • K935910 — X-RAY PACKING SPONGE (Jan 31, 1994)
  • K935881 — SPECIALTY SPONGES (Jan 31, 1994)
  • K935911 — PACKING SPONGE (Jan 31, 1994)
  • K935941 — READY CUT GAUZE GAUZE BOLTS (Jan 14, 1994)
  • K935935 — BURN GAUZE PADS (Jan 14, 1994)

Other clearances for product code EFQ

  • K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE (Aug 12, 1999)
  • K991215 — SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S (Jun 11, 1999)
  • K990974 — VITOP DRESSING (Jun 9, 1999)
  • K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE (Apr 23, 1999)
  • K984187 — CROSSTEX NON-WOVEN SPONGES (Feb 18, 1999)
  • K983016 — GAUZE, SPONGES, CAT # 11-003 (Feb 12, 1999)
  • K983348 — DYNAREX TRACHEOSTOMY SPONGE (Dec 11, 1998)
  • K983450 — STARRYSHINE GAUZE SPONGE (Nov 12, 1998)
  • K982648 — JOAN II (Sep 30, 1998)
  • K980791 — DUMEX PAK-ITS WOVEN RIBBON PACKING (Apr 29, 1998)

FDA data resources

Source: FDA 510(k) database entry for K935942. Report a data issue: hello@regdatalab.com.