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510(k) K936038

SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR) by Surgical Laser Technologies, Inc. — Product Code FJL

K936038 is an FDA 510(k) premarket notification submitted by Surgical Laser Technologies, Inc. for the device "SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR)". The FDA issued a decision of Substantially Equivalent on May 27, 1994. The device falls under product code FJL (Resectoscope), a Class II device regulated under 21 CFR 876.1500. Surgical Laser Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1994
Date Received
December 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resectoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Surgical Laser Technologies, Inc.

  • K042211 — MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS (November 8, 2004)
  • K023624 — SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-676 (January 27, 2003)
  • K011409 — SLT LASERPRO CTH HOLMIUM LASER SYSTEM (June 14, 2001)
  • K010041 — SLT DIFFUSER FIBER (March 7, 2001)
  • K984018 — HEMOSLEEVE, MODEL 4.0MM, 5.5MM (March 15, 1999)
  • K983050 — PNEUMATIC CUTTER SYSTEM (November 25, 1998)
  • K981041 — SLT BIPOLAR SHEATH (August 27, 1998)
  • K972548 — SLT CL MD CONTACT LASER SYSTEM (April 21, 1998)
  • K980156 — SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS (February 27, 1998)
  • K960821 — SLT FUMICH PROBE GUIDE (May 16, 1996)

Other clearances for product code FJL

  • K232486 — KARL STORZ Monopolar Resectoscopes with HF Cable (May 7, 2024)
  • K221893 — KARL STORZ Bipolar Resectoscopes with HF Cable (March 17, 2023)
  • K230205 — Veloxion System (February 24, 2023)
  • K191341 — Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Velo (June 13, 2019)
  • K190099 — Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Velo (March 15, 2019)
  • K162979 — Veloxion System (March 24, 2017)
  • K102663 — AED RESECTOSCOPE (December 30, 2010)
  • K062720 — S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES (March 22, 2007)
  • K042523 — RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSOR (March 18, 2005)
  • K041610 — MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 (August 19, 2004)

FDA data resources