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510(k) K894592

LAMANO DIRECTORS by Marlo Surgical Technology — Product Code GCM

K894592 is an FDA 510(k) premarket notification submitted by Marlo Surgical Technology for the device "LAMANO DIRECTORS". The FDA issued a decision of Substantially Equivalent on September 8, 1989. The device falls under product code GCM (Endoscope, Rigid), a Class II device regulated under 21 CFR 876.1500. Marlo Surgical Technology has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1989
Date Received
July 24, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
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)
  • K914872 — MARLOW SUCTION/IRRIGATION PROBES (November 19, 1991)

Other clearances for product code GCM

  • K203226 — TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM (May 14, 2021)
  • K083840 — MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE (September 28, 2009)
  • K001217 — INSIDE VIEW (July 11, 2000)
  • K993103 — ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOS (December 10, 1999)
  • K993445 — OMNISONIC ENDOSCOPIC DEFLECTOR (December 6, 1999)
  • K962393 — KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION (September 17, 1996)
  • K950712 — PORTABLE ENDOSCOPY SYSTEM (May 14, 1996)
  • K955120 — HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR (January 26, 1996)
  • K935235 — ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY (March 23, 1995)
  • K945889 — KARL STORZ PLASTIC SURGERY ACCESSORIES (March 22, 1995)

FDA data resources