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510(k) K921402

SURGICAL INSTRUMENT, DISPOSABLE by Macro Medical, Inc. — Product Code LXH

K921402 is an FDA 510(k) premarket notification submitted by Macro Medical, Inc. for the device "SURGICAL INSTRUMENT, DISPOSABLE". The FDA issued a decision of Substantially Equivalent on June 4, 1992. The device falls under product code LXH (Orthopedic Manual Surgical Instrument), a Class I device regulated under 21 CFR 888.4540.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1992
Date Received
March 24, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Manual Surgical Instrument
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

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  • K943873 — ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY (April 26, 1995)
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  • K941896 — STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR (November 7, 1994)
  • K941711 — HYPERFLEX FLEXIBLE GUIDEWIRES (August 26, 1994)
  • K941605 — STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH (August 5, 1994)

FDA data resources