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510(k) K910978

ACCU-BEAM LAPAROSCOPIC SYSTEM by Tti Medical — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1991
Date Received
March 7, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Tti Medical

  • K952006 — ACCU-BEAM FIBER OPTIC HANDPIECE (May 31, 1995)
  • K951895 — ACCU-BEAM 300W XENON LIGHT SOURCE (May 24, 1995)
  • K945648 — ACCU-BEAM C02 LASER HANDPIECE (February 24, 1995)
  • K921208 — ACCU-BEAM TUBE SET (June 1, 1993)
  • K895656 — ACCU-BEAM WAVEGUIDE (February 22, 1990)
  • K890922 — ACCU-BEAM YAG FIBER (May 15, 1989)
  • K870063 — CO2 LASER BRONCHOSCOPE SET (March 9, 1987)
  • K870046 — DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET (March 5, 1987)

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