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510(k) K914872

MARLOW SUCTION/IRRIGATION PROBES by Marlo Surgical Technology — Product Code GSJ

K914872 is an FDA 510(k) premarket notification submitted by Marlo Surgical Technology for the device "MARLOW SUCTION/IRRIGATION PROBES". The FDA issued a decision of Substantially Equivalent on November 19, 1991. The device falls under product code GSJ (Antiserum, Fluorescent, Francisella Tularensis), a Class II device regulated under 21 CFR 866.3280. Marlo Surgical Technology has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1991
Date Received
October 29, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Fluorescent, Francisella Tularensis
Device Class
Class II
Regulation Number
866.3280
Review Panel
MI
Submission Type

Other clearances by Marlo Surgical Technology

  • K960810 — BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35M (October 21, 1996)
  • K962273 — MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST (July 31, 1996)
  • K924611 — IRRIGATION PUMP AND TUBING SET (June 30, 1994)
  • K932634 — NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURES (February 25, 1994)
  • K932832 — PRIMUS INSULATED FORCEPS (February 25, 1994)
  • K920611 — MARLOW LAPAROSCOPIC GRASPING FORCEP (April 20, 1993)
  • K914153 — OTT INSUFFLATOR FILTER PLUS/TUBING SET (April 2, 1992)
  • K914869 — MARLOW LAPAROSCOPIC SCISSORS (January 15, 1992)
  • K913954 — MARLOW/REDDICK LAPAROSCOPIC NEEDLE HOLDERS (December 18, 1991)
  • K913964 — MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS (October 23, 1991)

FDA data resources