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510(k) K812694

WHISK-R by Medi-Spec — Product Code GEE

K812694 is an FDA 510(k) premarket notification submitted by Medi-Spec for the device "WHISK-R". The FDA issued a decision of Substantially Equivalent on October 26, 1981. The device falls under product code GEE (Brush, Biopsy, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Medi-Spec has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1981
Date Received
September 22, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Medi-Spec

  • K833068 — LAMINARIA JAPONICA CERVICAL DILATOR (February 4, 1984)
  • K812426 — UTERINE ASPIRATION CURETTES(RIGID&FLEX) (October 8, 1981)
  • K801554 — STERILE CAST PADDING (August 4, 1980)
  • K800404 — MEDSPEC OPERATIVE OPTHALMIC KIT (April 24, 1980)
  • K800490 — STERILE DRESSING PACK (March 12, 1980)
  • K790952 — CLAMP COVERS (June 5, 1979)
  • K780548 — DISPOSA-LOOPS (August 21, 1978)

Other clearances for product code GEE

  • K854003 — STERILE SOFT TISSUE BIOPSY NEEDLE (October 18, 1985)
  • K841008 — BIOPSY PUNCH, VARIOUS (June 8, 1984)
  • K822490 — DEFLECTING CYTOLOGY BRUSH (September 14, 1982)
  • K820259 — STERILE CYTOLOGY BRUSHES (March 5, 1982)
  • K801304 — CAMLOC SYRINGE BIOPSY KIT (June 17, 1980)
  • K792316 — TROTEX II SCREW NEEDLE BIOPSY INSTR. SET (December 18, 1979)

FDA data resources