Cleared Traditional

K972077 - EPI-STOP EPISTAXIS CATHETER

K972077 is an FDA 510(k) clearance for EPI-STOP EPISTAXIS CATHETER, manufactured by Boston Medical Products, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code EMX cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K972077 · Boston Medical Products, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
23d
Days
Class 1
Risk

K972077 is an FDA 510(k) clearance for the EPI-STOP EPISTAXIS CATHETER. Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by Boston Medical Products, Inc. (Westborough, US). The FDA issued a Cleared decision on June 26, 1997 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4100 - 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 Boston Medical Products, Inc. devices

FDA 510(k) Submission Details - K972077

510(k) Number K972077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1997
Decision Date June 26, 1997
Days to Decision 23 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
66d faster than avg
Panel avg: 89d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

EMX Device Classification - Class 1, General Controls

Product Code EMX Balloon, Epistaxis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EMX Balloon, Epistaxis

All 17
Devices cleared under the same product code (EMX) and FDA review panel - the closest regulatory comparables to K972077.
RHINOCELL NASAL PACKINGS
K972459 · Boston Medical Products, Inc. · Aug 1997
POST-STOP EPISTAXIS CATHETER
K972078 · Boston Medical Products, Inc. · Jul 1997
EPI-MAX EPISTAXIS CATHETER
K972076 · Boston Medical Products, Inc. · Jun 1997
HYDROCELL NASAL AND SINUS PACKS
K954491 · Smith & Nephew Richards, Inc. · Nov 1995
EPISTAXIS BALLOON CATHETER WITH PACKING
K945554 · Ultracell Medical Technologies, Inc. · Feb 1995
ANTERIOR/POSTERIOR EPISTAXIS CATHETER
K945556 · Ultracell Medical Technologies, Inc. · Jan 1995