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510(k) K791703

TEW BYPASS INSTRUMENTS & DISSECTING KIT by Edward Weck, Inc. — Product Code GDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1979
Date Received
August 28, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dissector, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Edward Weck, Inc.

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  • 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)
  • K902232 — WECK ELECTROSURGICAL GENERATOR #174200 (August 2, 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)

Other clearances for product code GDI

  • K896383 — DISPOSABLE EXTERNAL CLAMPS (December 6, 1989)
  • K850288 — HEPATIC PARENCHYMAL SUCTION DISSECTOR (March 18, 1985)
  • K831912 — ROUND-BEEHIVE- DISSECTORS 3/8 (October 31, 1983)
  • K822569 — TYMPANOPLASTY & SKIN DISSECTORS (October 6, 1982)
  • K803292 — FIELD SUCTION DISSECTOR (January 29, 1981)
  • K791870 — DISPOSABLE SPECIALITY SPONGES (November 5, 1979)