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510(k) K982260

MARKWELL GAUZE SPONGE by Markwell Intl., Inc. — Product Code LWH

K982260 is an FDA 510(k) premarket notification submitted by Markwell Intl., Inc. for the device "MARKWELL GAUZE SPONGE". The FDA issued a decision of Substantially Equivalent on August 12, 1998. The device falls under product code LWH (Counter, Sponge, Surgical), a Class I device regulated under 21 CFR 880.2740.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1998
Date Received
June 26, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Sponge, Surgical
Device Class
Class I
Regulation Number
880.2740
Review Panel
SU
Submission Type

Other clearances for product code LWH

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  • K120473 — PIXEL APP (April 9, 2012)
  • K100551 — ORLOCATE SYSTEM MODEL ORL 100 (August 12, 2010)
  • K093557 — SMARTWAND-DTX (December 18, 2009)
  • K073180 — SMARTSPONGE PLUS SYSTEM (November 19, 2007)
  • K071355 — SMARTSPONGE SYSTEM (May 24, 2007)
  • K061316 — MEDLINE SURGICAL SPONGE SCANNER (November 2, 2006)
  • K062642 — RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A (November 2, 2006)
  • K060076 — SURGICOUNT SAFETY-SPONGE SYSTEM (March 14, 2006)
  • K972302 — POCKET COUNT OR SAFETCOUNT (July 25, 1997)

FDA data resources