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510(k) K871710

BIOPSY FORCEPS by Frantz Medical Development, Ltd. — Product Code FCL

K871710 is an FDA 510(k) premarket notification submitted by Frantz Medical Development, Ltd. for the device "BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on August 10, 1987. The device falls under product code FCL (Forceps, Biopsy, Non-Electric), a Class I device regulated under 21 CFR 876.1075. Frantz Medical Development, Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1987
Date Received
May 1, 1987
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 Frantz Medical Development, Ltd.

  • K981541 — CLEARSTAR ENTERAL NUTRITION PUMP (August 13, 1998)
  • K905282 — ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE (March 19, 1991)
  • K873119 — FLEXIFLO COMPANION ENTERAL NUTRITION PUMP (November 5, 1987)
  • K863508 — FRANTZ MEDICAL ELECTRODE (February 6, 1987)

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