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510(k) K902232

WECK ELECTROSURGICAL GENERATOR #174200 by Edward Weck, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1990
Date Received
May 17, 1990
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 Edward Weck, Inc.

  • K915378 — WECK TROCAR (June 29, 1992)
  • K914690 — LM15(TM), CATALOG NUMBER - 523821 (March 23, 1992)
  • K911915 — HEMOCLIP II (January 9, 1992)
  • K914470 — PNEUMO-SEAL(TM) (November 29, 1991)
  • K911272 — ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705 (July 2, 1991)
  • K902108 — HEM-O-LOK(TM) (August 6, 1990)
  • K897045 — BOWIE-DICK TEST CARD CATALOG NUMBER 008018 (February 15, 1990)
  • K871110 — CORONARY ARTERY BYPASS GRAFT (CABG) MARKER (August 27, 1987)
  • K851251 — AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200 (July 2, 1985)
  • K851258 — WECK LX TM SKIN STAPLER (June 7, 1985)

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