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510(k) K981672

RADIOTHERAPEUTICS RF-2000 RADIOFREQUENCY GENERATOR by Radiotherapeutics Corp. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1998
Date Received
May 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 Radiotherapeutics Corp.

  • K011220 — LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE (July 1, 2002)
  • K012315 — LEVEEN ELECTRODE (October 11, 2001)
  • K000241 — RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR (April 14, 2000)
  • K982556 — LEVEEN NEEDLE ELECTRODE (April 6, 2000)
  • K000032 — LEVEEN NEEDLE ELECTRODE (March 30, 2000)
  • K982854 — MR COMPATIBLE LEVEEN NEEDLE ELECTRODE (November 10, 1998)
  • K972441 — RADIOTHERAPEUTICS RF GENERATOR. MODEL #RF-2000 (September 4, 1997)
  • K962313 — MODIFIED LEVEEN NEEDLE ELECTRODE (September 11, 1996)
  • K962386 — SENSOR SHEATH TS1 (August 20, 1996)
  • K955144 — RADIOTHERAPEUTICS RF GENERATOR MODEL RF-1000 (April 7, 1996)

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