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510(k) K912839

LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE by Baxter Healthcare Corp — Product Code FBW

K912839 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE". The FDA issued a decision of Substantially Equivalent on September 25, 1991. The device falls under product code FBW (Filiform And Filiform Follower), a Class I device regulated under 21 CFR 876.5520. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1991
Date Received
June 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filiform And Filiform Follower
Device Class
Class I
Regulation Number
876.5520
Review Panel
GU
Submission Type

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  • K123874 — INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS (January 10, 2013)
  • K123868 — INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, (January 8, 2013)

FDA data resources