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510(k) K971178

RAND SURGICAL SPONGE by Trans Aire — Product Code EFQ

K971178 is an FDA 510(k) premarket notification submitted by Trans Aire for the device "RAND SURGICAL SPONGE". The FDA issued a decision of Substantially Equivalent on Jun 27, 1997. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 27, 1997
Date Received
Mar 31, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze/Sponge, Internal
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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