Home / 510(k) Clearances / K011488

510(k) K011488

SPIRABRUSH CX BIOPSY INSTRUMENT by Trylon Corp. — Product Code HFB

K011488 is an FDA 510(k) premarket notification submitted by Trylon Corp. for the device "SPIRABRUSH CX BIOPSY INSTRUMENT". The FDA issued a decision of Substantially Equivalent on February 22, 2002. The device falls under product code HFB (Forceps, Biopsy, Gynecological), a Class I device regulated under 21 CFR 884.4530. Trylon Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2002
Date Received
May 15, 2001
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 Trylon Corp.

  • K033033 — VIZILITE-BLUE ORAL EXAM KIT (November 22, 2004)
  • K012070 — ORALLITE COMPREHENSIVE EXAM TRAY (November 27, 2001)
  • K003995 — SPECULITE/ORALLITE (March 16, 2001)
  • K963391 — SPECULITE (December 12, 1997)
  • K955790 — PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY (March 21, 1996)
  • K953364 — SPECULITE (December 8, 1995)

Other clearances for product code HFB

  • 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)
  • K895303 — EVER-SHARP BIOPSY FORCEPS (January 16, 1990)

FDA data resources