Cleared Traditional

K951048 - RITE-BITE BIOPSY FORCEPS

K951048 is the FDA 510(k) clearance for RITE-BITE BIOPSY FORCEPS by Mill-Rose Laboratory. It is a Class 1 Gastroenterology & Urology device (product code FCL) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K951048 · Mill-Rose Laboratory · Gastroenterology & Urology device
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Mar 1995
Decision
9d
Days
Class 1
Risk

K951048 is an FDA 510(k) clearance for the RITE-BITE BIOPSY FORCEPS. Classified as Forceps, Biopsy, Non-electric (product code FCL), Class I - General Controls.

Submitted by Mill-Rose Laboratory (Mentor, US). The FDA issued a Cleared decision on March 15, 1995 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mill-Rose Laboratory devices

Submission Details

510(k) Number K951048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1995
Decision Date March 15, 1995
Days to Decision 9 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 130d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FCL Forceps, Biopsy, Non-electric
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1075
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FCL Forceps, Biopsy, Non-electric

All 9
Devices cleared under the same product code (FCL) and FDA review panel - the closest regulatory comparables to K951048.
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K971315 · Richard Wolf Medical Instruments Corp. · Sep 1997
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K955065 · Olympus America, Inc. · Jan 1996
DIENER RETRIEVAL DEVICES
K950559 · Mill-Rose Laboratory · Feb 1995
SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS
K946238 · Symbiosis Corp. · Jan 1995
GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS
K935070 · KARL STORZ Endoscopy-America, Inc. · Jan 1994
BARD SINGULAR BIOPSY FORCEPS
K914212 · C.R. Bard, Inc. · Nov 1991