Home / 510(k) Clearances / K984018

510(k) K984018

HEMOSLEEVE, MODEL 4.0MM, 5.5MM by Surgical Laser Technologies, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1999
Date Received
November 12, 1998
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 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)
  • 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)
  • K954727 — SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM (MODIFICATION) (February 5, 1996)

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