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510(k) K842997

LASER RECTOSCOPE SET 784 by Laser Industries , Ltd. — Product Code FDC

K842997 is an FDA 510(k) premarket notification submitted by Laser Industries , Ltd. for the device "LASER RECTOSCOPE SET 784". The FDA issued a decision of Substantially Equivalent on August 27, 1984. The device falls under product code FDC (Resectoscope, Working Element), a Class II device regulated under 21 CFR 876.1500. Laser Industries , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1984
Date Received
July 30, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Laser Industries , Ltd.

  • K933362 — SHARPLAN CO2 SURGICAL LASER (April 7, 1994)
  • K894765 — SHARPLAN SMOKE EVACUATION UNIT, MODEL 100 (September 28, 1989)
  • K850633 — SHARPLAN MODEL 1060 CO/2 SURGICAL LASER (August 7, 1985)
  • K850628 — SHARPLAN 1040 CO/2 SURGICAL LASER (August 7, 1985)
  • K832550 — SHARPLAN #734 LASER SURGICAL UNIT (April 25, 1984)
  • K832551 — SHARPLAN #745 LASER SURG. UNIT (April 23, 1984)
  • K832316 — OPHTHALMIC ARGON LASER #700A (January 30, 1984)
  • K837573 — SHARPLAN LASER POSITIONING SYSTEM (June 28, 1983)
  • K837342 — SHARPLAN 721 CO2 SURGICAL LASER (May 18, 1983)
  • K837081 — MICROSCAN 771 MANIPULATOR (March 9, 1983)

Other clearances for product code FDC

  • K021166 — ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR (May 9, 2002)
  • K992141 — OLYMPUS WORKING ELEMENT FOR PROBES (September 29, 1999)
  • K991426 — MAHE INSTRUMENTS (August 5, 1999)
  • K942626 — CONTINUOUS FLOW BIOPSY PROBE (May 30, 1995)
  • K933962 — GM CONTINUOUS FLOW BIOPSY PROBE (February 25, 1994)
  • K895643 — MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM (October 17, 1989)
  • K894363 — UROPUMP* FLUID MANAGEMENT SYSTEM (August 11, 1989)
  • K760184 — ELEMENT, WORKING (December 2, 1976)
  • K760182 — SHEATH, RESECTOSCOPE (December 2, 1976)
  • K760174 — ADAPTER, RESECTOSCOPE (August 30, 1976)

FDA data resources