Cleared Traditional

K895415 - BIOPSY FORCEPS

K895415 is an FDA 510(k) clearance for BIOPSY FORCEPS, manufactured by Symbiosis Corp.. The device is a Class 2 Ear, Nose, Throat device with product code EOQ cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K895415 · Symbiosis Corp. · Ear, Nose, Throat device
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Oct 1989
Decision
56d
Days
Class 2
Risk

K895415 is an FDA 510(k) clearance for the BIOPSY FORCEPS. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Symbiosis Corp. (Miami, US). The FDA issued a Cleared decision on October 31, 1989 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4680 - the FDA ear, nose and throat 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 - K895415

510(k) Number K895415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1989
Decision Date October 31, 1989
Days to Decision 56 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 89d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EOQ Device Classification - Class 2, Special Controls

Product Code EOQ Bronchoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition A Bronchoscope (flexible Or Rigid) And Accessories Is A Tubular Endoscopic Device With Any Of A Group Of Accessory Devices Which Attach To The Bronchoscope And Is Intended To Examine Or Treat The Larynx And Tracheobronchial Tree. If The Device Is Reprocessed, Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EOQ Bronchoscope (flexible Or Rigid)

All 187
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K895415.
OLYMPUS DISPOSABLE BIOPSY VALVE
K911412 · Olympus Corp. · Jun 1991
BRONCHOSCOPE BF-N20
K910423 · Olympus Corp. · Apr 1991
EXMOOR BITE BUFFER
K893006 · Exmoor Plastics , Ltd. · Mar 1990
CANNULATED BIOPSY FORCEPS
K892687 · Zinnanti Surgical Instruments, Inc. · Jun 1989
CO2 FIBEROPTIC DELIVERY SYSTEM/BRONCHOSCOPIC USE
K862835 · Cooper Lasersonics, Inc. · Feb 1987
LARYNGOTELESCOPE CURVED MLC-1
K832449 · Pentax Precision Instrument Corp. · Sep 1983