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510(k) K854890

HOOK PROBE by Euro-Med Intl. — Product Code KDC

K854890 is an FDA 510(k) premarket notification submitted by Euro-Med Intl. for the device "HOOK PROBE". The FDA issued a decision of Substantially Equivalent on May 2, 1986. The device falls under product code KDC (Instrument, Surgical, Disposable), a Class I device regulated under 21 CFR 878.4800. Euro-Med Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1986
Date Received
December 6, 1985
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 by Euro-Med Intl.

  • K883884 — PROSTATIC CORE-CUT NEEDLE (December 5, 1988)
  • K882404 — KEVOR-CURETTE (July 8, 1988)
  • K854891 — KNIFE (May 2, 1986)
  • K854897 — MAX-I-GRASP (May 2, 1986)
  • K854898 — ATLANTIC GRASPER (May 2, 1986)
  • K854896 — HOOK SCISSOR (May 2, 1986)
  • K854894 — SPOON (May 2, 1986)
  • K854895 — BASKET FORCEP (May 2, 1986)
  • K854901 — PACIFIC GRASPER (May 2, 1986)
  • K854889 — FLEX-I-GRASP (February 21, 1986)

Other clearances for product code KDC

  • K943229 — DISPOSABLE SURGICAL SCISSORS AND FORCEPS (August 19, 1994)
  • 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)

FDA data resources