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510(k) K923378

USP TYPE VII GAUZE SPONGES by E.W.A., Ltd. — Product Code NAB

K923378 is an FDA 510(k) premarket notification submitted by E.W.A., Ltd. for the device "USP TYPE VII GAUZE SPONGES". The FDA issued a decision of Substantially Equivalent on October 6, 1992. The device falls under product code NAB (Gauze / Sponge,Nonresorbable For External Use), a Class I device regulated under 21 CFR 878.4014. E.W.A., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1992
Date Received
July 9, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze / Sponge,Nonresorbable For External Use
Device Class
Class I
Regulation Number
878.4014
Review Panel
SU
Submission Type

Other clearances by E.W.A., Ltd.

  • K943339 — GAUZE SPONGE (E.W.A. LTD./VARIOUS) (August 23, 1994)

Other clearances for product code NAB

  • K946015 — IVALON EXTERNAL SPONGE (February 27, 1995)
  • K940755 — ISOLYER (4X4, 8PLY) (May 2, 1994)
  • K931610 — OMNISORB II, NONWOVEN SPONGE, STERILE AND NON (June 24, 1993)
  • K925590 — MULTI-TRAUMA DRESSING (April 8, 1993)
  • K926072 — K-BAND AND K-CREPE (March 19, 1993)
  • K915591 — STERILE GAUZE PADS (January 27, 1993)
  • K924650 — GAUZE SPONGES (January 11, 1993)
  • K923602 — ABSORBENT PAD -- MODIFICATION (December 7, 1992)
  • K923115 — CLINISORB (November 23, 1992)
  • K923116 — COMBINE II WETPROOF PAD (October 6, 1992)

FDA data resources