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510(k) K972350

MODEL 50 BIPOLAR COAGULATOR by Boston Surgical Products, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1997
Date Received
June 24, 1997
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 Boston Surgical Products, Inc.

  • K972311 — MODEL 20 BIPOLAR COAGULATOR (September 18, 1997)
  • K944947 — ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESS (July 28, 1995)
  • K953012 — DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS (July 12, 1995)
  • K950375 — DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATOR (June 14, 1995)
  • K951912 — DISOPOSABLE & RESUABLE MONPOLAR CORD (May 12, 1995)
  • K951269 — DISPOSABLE & REUSABLE MONOPOLAR HANDSWITHC PENCIL (April 24, 1995)
  • K950877 — REUSABLE MONOPOLAR FORCEPS (March 9, 1995)
  • K945171 — DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE (February 8, 1995)
  • K945893 — DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODE (December 13, 1994)
  • K944578 — BIPOLAR CORD (December 8, 1994)

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