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510(k) K935250

ACCU-PATH by Cox Medical Ent., Inc. — Product Code FCL

K935250 is an FDA 510(k) premarket notification submitted by Cox Medical Ent., Inc. for the device "ACCU-PATH". The FDA issued a decision of Substantially Equivalent on January 21, 1994. The device falls under product code FCL (Forceps, Biopsy, Non-Electric), a Class I device regulated under 21 CFR 876.1075. Cox Medical Ent., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1994
Date Received
November 1, 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 Cox Medical Ent., Inc.

  • K946360 — MODULAR BIOPSY FORCEP (March 6, 1995)
  • K950689 — UCB (March 6, 1995)
  • K941464 — BASICS ENDOSCOPY SYSTEM (August 5, 1994)
  • K940911 — BASICS ENDOSCOPY SYSTEM (May 16, 1994)
  • K932790 — THERMAL OPTION (January 28, 1994)
  • K924655 — COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2) (December 15, 1992)
  • K923671 — COX DISPOSABLE POLYPECTOMY SNARES (October 13, 1992)
  • K923672 — COX DISPOSABLE ENDOSCOPE CLEANING BRUSH (September 23, 1992)
  • K923489 — COX DISPOSABLE RETRIEVAL DEVICES (September 23, 1992)
  • K914466 — COX DISPOSABLE CYTOLOGY BRUSHES (October 25, 1991)

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