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510(k) K951048

RITE-BITE BIOPSY FORCEPS by Mill-Rose Laboratory — Product Code FCL

K951048 is an FDA 510(k) premarket notification submitted by Mill-Rose Laboratory for the device "RITE-BITE BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on March 15, 1995. The device falls under product code FCL (Forceps, Biopsy, Non-Electric), a Class I device regulated under 21 CFR 876.1075. Mill-Rose Laboratory has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1995
Date Received
March 6, 1995
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 Mill-Rose Laboratory

  • K983122 — MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOL (October 30, 1998)
  • K983124 — MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDUR (October 30, 1998)
  • K971275 — MILL-ROSE DISPOSABLE POLYPECTOMY SNARE (May 23, 1997)
  • K962736 — MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE (July 29, 1996)
  • K960880 — MILL-ROSE BLIND MICROBIOLOGY BRUSH (April 29, 1996)
  • K954519 — WANG TRANSENDOSCOPIC ASPIRATION NEEDLE (December 22, 1995)
  • K951600 — MILL-ROSE ROTATABLE POLYPECTOMY SNARE (December 18, 1995)
  • K954745 — MILL-ROSE RIGID SCOPE CLEANING BRUSHES (November 27, 1995)
  • K951051 — RITE-BITE BIOPSY FORCEPS (March 24, 1995)
  • K946293 — MILL-ROSE SCOPE CLEANING BRUSH (February 16, 1995)

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)
  • K946360 — MODULAR BIOPSY FORCEP (March 6, 1995)
  • K950559 — DIENER RETRIEVAL DEVICES (February 16, 1995)

FDA data resources