Cleared Traditional

TROCARS,CANNULAE, SHEATHS (K943816) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K943816 · Karl Storz Endoskop GmbH · Ear, Nose, Throat device
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Aug 1994
Decision
19d
Days
Class 2
Risk

K943816 is an FDA 510(k) clearance for the TROCARS,CANNULAE, SHEATHS. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Karl Storz Endoskop GmbH (Culver City, US). The FDA issued a Cleared decision on August 24, 1994 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4760 - 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 Karl Storz Endoskop GmbH devices

Submission Details

510(k) Number K943816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1994
Decision Date August 24, 1994
Days to Decision 19 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 89d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EOB Nasopharyngoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4760
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 - EOB Nasopharyngoscope (flexible Or Rigid)

All 72
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K943816.
SINUSCOPE
K944186 · Stryker Endoscopy · Nov 1994
KARL STORZ OPTICAL VIDEO TONGUE DEPRESSOR
K944296 · KARL STORZ Endoscopy-America, Inc. · Oct 1994
NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS
K943665 · Olympus America, Inc. · Oct 1994
FORCEPS, PUNCHES, SCISSORS
K943074 · KARL STORZ Endoscopy-America, Inc. · Aug 1994
ACCESSORIES FOR ENDOSCOPES FOR SINUS SURGERY
K932988 · Smith & Nephew Richards, Inc. · Jul 1993
NASAL/PARANASAL ENDOSCOPE
K930931 · Storz Instrument Co. · May 1993