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510(k) K772384

MYRINGOTOMY KNIFE by Edward Weck, Inc. — Product Code JYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1978
Date Received
December 27, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Knife, Ear
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

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)
  • 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 JYO

  • K910212 — COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST (July 11, 1991)
  • K841006 — EAR KNIFE-VARIOUS (May 30, 1984)
  • K840764 — EAR KNIVES (May 21, 1984)
  • K833602 — ROLLER KNIFE-TRANSVERSE -SAGITTAL (January 3, 1984)
  • K823911 — KNIFE BLADE TIP (January 21, 1983)
  • K772372 — ROLLER KNIFE (January 17, 1978)