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510(k) K943229

DISPOSABLE SURGICAL SCISSORS AND FORCEPS by Y.M.K. International Co., Ltd. — Product Code KDC

K943229 is an FDA 510(k) premarket notification submitted by Y.M.K. International Co., Ltd. for the device "DISPOSABLE SURGICAL SCISSORS AND FORCEPS". The FDA issued a decision of Substantially Equivalent on August 19, 1994. The device falls under product code KDC (Instrument, Surgical, Disposable), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1994
Date Received
July 6, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances for product code KDC

  • K936226 — SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET (March 7, 1994)
  • K920153 — THERMUFF BAG (July 1, 1992)
  • K920263 — MANUAL SURGICAL INSTRUMENTS (May 6, 1992)
  • K915064 — DISPOSABLE CAUTERY ABRASIVE PAD (March 11, 1992)
  • K914960 — INSTRUMENT ORGANIZER (February 28, 1992)
  • K912834 — SHUR-GRIP (July 26, 1991)
  • K910079 — DISPOSABLE INTRODUCER SHEATH (February 27, 1991)
  • K905240 — VESSELOOPS (February 6, 1991)
  • K903649 — BRADLEY TENACULUM HOLDER (November 2, 1990)
  • K900566 — RICHARD-ALLAN VESSEL LOOPS (May 3, 1990)

FDA data resources