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510(k) K802458

KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611 by J. Sklar Mfg. Co., Inc. — Product Code HFB

K802458 is an FDA 510(k) premarket notification submitted by J. Sklar Mfg. Co., Inc. for the device "KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611". The FDA issued a decision of Substantially Equivalent on January 12, 1981. The device falls under product code HFB (Forceps, Biopsy, Gynecological), a Class I device regulated under 21 CFR 884.4530. J. Sklar Mfg. Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1981
Date Received
October 8, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Biopsy, Gynecological
Device Class
Class I
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by J. Sklar Mfg. Co., Inc.

  • K843693 — JACOBS HIGH VACUUM SUCTION UNIT 05-2570 (October 31, 1984)
  • K842112 — TISCHLER CERVICAL BIOPSY PUNCH FORCEPS (July 3, 1984)
  • K842111 — KOGAN ENDOSPECULUM 9-1/2 (June 19, 1984)
  • K822448 — SCISSORS, VARIOUS (September 14, 1982)
  • K802457 — KEVORKIAN-YOUNGE BIOPSY PUNCH, #90-6610 (January 12, 1981)
  • K801273 — MAGILL CATHETER INTRO. FORCEPS (July 28, 1980)
  • K800441 — RUDD-CLINIC HEMORRHOIDAL FORCEPS (April 8, 1980)
  • K790577 — HEMORRHOIDAL LIGATOR (April 23, 1979)
  • K772229 — MINICLAMPS, STABILIZ., FALLOPIAN TUBE (January 3, 1978)
  • K772230 — CANNULA, PERFUSION, FALLOPIAN TUBE (January 3, 1978)

Other clearances for product code HFB

  • K011488 — SPIRABRUSH CX BIOPSY INSTRUMENT (February 22, 2002)
  • K944444 — CIT BIOPSY PUNCHES (September 29, 1995)
  • K930773 — SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS (July 28, 1994)
  • K933767 — FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY (May 26, 1994)
  • K926595 — OWENS BIOPSY FORCEPS (May 25, 1994)
  • K926527 — ROTO FIT BIOPSY FORCEPS (February 25, 1994)
  • K930036 — THOMAS MEDICAL BIOPSY FORCEPS (February 24, 1994)
  • K926538 — TISCHLER BIOPSY FORCEPS (February 24, 1994)
  • K924224 — OWENS BIOPSY FORCEPS (February 4, 1994)
  • K902049 — CROAK OVARIAN BIOPSY FORCEP (June 7, 1990)

FDA data resources