Cleared Traditional

K934193 - CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RE...

K934193 is the FDA 510(k) clearance for CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RE... by Biosearch Medical Products, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EOX) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K934193 · Biosearch Medical Products, Inc. · Ear, Nose, Throat device
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Nov 1993
Decision
85d
Days
Class 2
Risk

K934193 is an FDA 510(k) clearance for the CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST. Classified as Esophagoscope (flexible Or Rigid) (product code EOX), Class II - Special Controls.

Submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on November 19, 1993 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4710 - 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 Biosearch Medical Products, Inc. devices

Submission Details

510(k) Number K934193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1993
Decision Date November 19, 1993
Days to Decision 85 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 89d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EOX Esophagoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4710
Definition 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 - EOX Esophagoscope (flexible Or Rigid)

All 25
Devices cleared under the same product code (EOX) and FDA review panel - the closest regulatory comparables to K934193.
KARL STORZ BOUGIES, SOUNDS, DILATORS
K946331 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
KARL STORZ SUCTYION/IRRIGATION TUBES, CANNULAE
K945237 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
ESOPHAGOSCOPE AND ACCESSORIES
K943667 · KARL STORZ Endoscopy-America, Inc. · Aug 1994
BRANDT ESOPHAGEAL CYTOLOGY BALLOON
K911588 · Wilson-Cook Medical, Inc. · Nov 1992
JESBERG ESOPHAGOSCOPE
K892259 · Zinnanti Surgical Instruments, Inc. · Jun 1989
JESBERG ESOPHAGOSCOPES W/AUSTINETIC S S
K760652 · Pilling Co. · Dec 1976