Home / 510(k) Clearances / K931957

510(k) K931957

SYMBIOSIS DISPOSABLE UROLOGICAL BIOPSY FORCEPS by Symbiosis Corp. — Product Code FCL

K931957 is an FDA 510(k) premarket notification submitted by Symbiosis Corp. for the device "SYMBIOSIS DISPOSABLE UROLOGICAL BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on February 28, 1994. The device falls under product code FCL (Forceps, Biopsy, Non-Electric), a Class I device regulated under 21 CFR 876.1075. Symbiosis Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1994
Date Received
April 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Biopsy, Non-Electric
Device Class
Class I
Regulation Number
876.1075
Review Panel
GU
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)
  • K930773 — SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS (July 28, 1994)
  • K941426 — SYMBIOSIS REUSABLE MONOPOLAR ELECTROSURGICAL PROBE (June 22, 1994)
  • K932266 — SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN (March 15, 1994)

Other clearances for product code FCL

  • K032092 — OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE (July 16, 2003)
  • K973611 — SPECTRASCIENCE REUSABLE BIOPSY FORCEPS (December 2, 1997)
  • K971315 — AUXILIARY INSTRUMENTS FOR URS (September 15, 1997)
  • K964120 — INJECTO FLUSH (December 30, 1996)
  • K963517 — SPECTRA SCIENCE BIOPSY FORCEPS (December 2, 1996)
  • K955065 — OLYMPUS FB SERIES BIOPSY FORCEPS (January 24, 1996)
  • K952863 — FORCEPS, BIOPSY, NON-ELECTRIC (July 19, 1995)
  • K952391 — DYNABITE UROLOGICAL FORCEPS (June 1, 1995)
  • K951048 — RITE-BITE BIOPSY FORCEPS (March 15, 1995)
  • K946360 — MODULAR BIOPSY FORCEP (March 6, 1995)

FDA data resources