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510(k) K852357

GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP by Gyneco, Inc. — Product Code HFB

K852357 is an FDA 510(k) premarket notification submitted by Gyneco, Inc. for the device "GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP". The FDA issued a decision of Substantially Equivalent on July 5, 1985. The device falls under product code HFB (Forceps, Biopsy, Gynecological), a Class I device regulated under 21 CFR 884.4530. Gyneco, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1985
Date Received
June 3, 1985
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 Gyneco, Inc.

  • K861409 — SYNCARE TEMPORARY CARDIAC PACING WIRE (May 5, 1986)
  • K853216 — MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4 (April 2, 1986)
  • K843941 — ENDOCYTE (February 25, 1985)
  • K841275 — FINE NEEDLE ASPIRATION DEVICE (August 17, 1984)

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