Cleared Traditional

K950559 - DIENER RETRIEVAL DEVICES

K950559 is an FDA 510(k) clearance for DIENER RETRIEVAL DEVICES, manufactured by Mill-Rose Laboratory. The device is a Class 1 Gastroenterology & Urology device with product code FCL cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K950559 · Mill-Rose Laboratory · Gastroenterology & Urology device
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Feb 1995
Decision
8d
Days
Class 1
Risk

K950559 is an FDA 510(k) clearance for the DIENER RETRIEVAL DEVICES. 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 February 16, 1995 after a review of 8 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.

FDA 510(k) Submission Details - K950559

510(k) Number K950559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1995
Decision Date February 16, 1995
Days to Decision 8 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
123d faster than avg
Panel avg: 131d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

FCL Device Classification - Class 1, General Controls

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 37
Devices cleared under the same product code (FCL) and FDA review panel - the closest regulatory comparables to K950559.
DYNABITE UROLOGICAL FORCEPS
K952391 · Portlyn Corp. · Jun 1995
RITE-BITE BIOPSY FORCEPS
K951048 · Mill-Rose Laboratory · Mar 1995
MODULAR BIOPSY FORCEP
K946360 · Cox Medical Ent., Inc. · Mar 1995
SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS
K946238 · Symbiosis Corp. · Jan 1995
LSVP INTERNATIONAL BIOPSY FORCEPS
K944770 · Lsvp Intl., Inc. · Oct 1994
EMC FLEXIBLE BIOPSY FORCEPS
K941816 · Enterprise Medical Corp. · Jul 1994
K950559 · DIENER RETRIEVAL DEVICES
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