Cleared Traditional

K894419 - GASTRO ENTEROLOGICAL BIOPTOME

K894419 is an FDA 510(k) clearance for GASTRO ENTEROLOGICAL BIOPTOME, manufactured by Symbiosis Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K894419 · Symbiosis Corp. · Gastroenterology & Urology device
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Sep 1989
Decision
53d
Days
Class 2
Risk

K894419 is an FDA 510(k) clearance for the GASTRO ENTEROLOGICAL BIOPTOME. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Symbiosis Corp. (Miami, US). The FDA issued a Cleared decision on September 8, 1989 after a review of 53 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 Symbiosis Corp. devices

FDA 510(k) Submission Details - K894419

510(k) Number K894419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1989
Decision Date September 08, 1989
Days to Decision 53 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 130d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNW Device Classification - Class 2, Special Controls

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 173
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K894419.
BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT
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MADAYAG, MANGHINI, FRANSEEN, GREEN, TROCAR NEEDLES
K895457 · Advance Medical Designs, Inc. · Nov 1989
STAMEY SAMPLER SPRING LOADED BIOPSY NEEDLE
K885169 · Boston Scientific Corp · Feb 1989
SIEMENS SECTOR 3.5 AND 5.0 MHZ CDA TRANSDUCER
K884900 · Siemens Medical Solutions USA, Inc. · Jan 1989
BARD(R) ASPIRATION BIOPSY SYSTEM
K883469 · C.R. Bard, Inc. · Jan 1989