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510(k) K930773

SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS by Symbiosis Corp. — Product Code HFB

K930773 is an FDA 510(k) premarket notification submitted by Symbiosis Corp. for the device "SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on July 28, 1994. The device falls under product code HFB (Forceps, Biopsy, Gynecological), a Class I device regulated under 21 CFR 884.4530. Symbiosis Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1994
Date Received
February 16, 1993
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 Symbiosis Corp.

  • K955119 — SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES (January 18, 1996)
  • K953453 — SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES (January 17, 1996)
  • K953242 — SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES (October 6, 1995)
  • K952432 — SYMBIOSIS BIPOLAR FORCEPS (July 5, 1995)
  • K951387 — SYMBIOSIS BIPOLAR SCISSORS (April 10, 1995)
  • K950286 — SYMBIOSIS BIPOLAR SCISSORS (February 3, 1995)
  • K946238 — SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS (January 20, 1995)
  • K941426 — SYMBIOSIS REUSABLE MONOPOLAR ELECTROSURGICAL PROBE (June 22, 1994)
  • K932266 — SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN (March 15, 1994)
  • K931957 — SYMBIOSIS DISPOSABLE UROLOGICAL BIOPSY FORCEPS (February 28, 1994)

Other clearances for product code HFB

  • K011488 — SPIRABRUSH CX BIOPSY INSTRUMENT (February 22, 2002)
  • K944444 — CIT BIOPSY PUNCHES (September 29, 1995)
  • 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