Home / 510(k) Clearances / K925392

510(k) K925392

BIOPSY FORCEPS by Endo-Therapeutics, Inc. — Product Code FCL

K925392 is an FDA 510(k) premarket notification submitted by Endo-Therapeutics, Inc. for the device "BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on November 5, 1993. The device falls under product code FCL (Forceps, Biopsy, Non-Electric), a Class I device regulated under 21 CFR 876.1075. Endo-Therapeutics, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1993
Date Received
October 26, 1992
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 Endo-Therapeutics, Inc.

  • K090796 — MULTI-BITE HOT BIOPSY FORCEPS (November 25, 2009)
  • K031026 — ETI BIPOLAR HEMOSTATIC PROBE (June 27, 2003)
  • K023603 — ENDO-GLIDE GUIDEWIRE (February 19, 2003)
  • K012725 — TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGER (November 8, 2001)
  • K012977 — VARICES INJECTION NEEDLE (November 2, 2001)
  • K926549 — ENDOCATH ELECTROPHYSIOLOGY CATHETER (December 6, 1993)

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