Cleared Traditional

K930931 - NASAL/PARANASAL ENDOSCOPE

K930931 is an FDA 510(k) clearance for NASAL/PARANASAL ENDOSCOPE, manufactured by Storz Instrument Co.. The device is a Class 2 Ear, Nose, Throat device with product code EOB cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K930931 · Storz Instrument Co. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
83d
Days
Class 2
Risk

K930931 is an FDA 510(k) clearance for the NASAL/PARANASAL ENDOSCOPE. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on May 17, 1993 after a review of 83 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 Storz Instrument Co. devices

FDA 510(k) Submission Details - K930931

510(k) Number K930931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1993
Decision Date May 17, 1993
Days to Decision 83 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 89d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EOB Device Classification - Class 2, Special Controls

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 105
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K930931.
FORCEPS, PUNCHES, SCISSORS
K943074 · KARL STORZ Endoscopy-America, Inc. · Aug 1994
PROTECTIVE SHEATH FOR FLEXIBLE NASOPHARY/LARYGNOS
K933247 · Vision-Sciences, Inc. · Nov 1993
ACCESSORIES FOR ENDOSCOPES FOR SINUS SURGERY
K932988 · Smith & Nephew Richards, Inc. · Jul 1993
ENDOSHEATH
K925421 · Vision-Sciences, Inc. · Jan 1993
DISPOSABLE PROTECTIVE SHEATH
K921244 · Vision-Sciences, Inc. · Oct 1992
PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2
K921707 · Pentax Precision Instrument Corp. · Jul 1992