Cleared Traditional

MIST ENDOSCOPIC NEEDLES (K951648) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K951648 · Mist, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
May 1995
Decision
32d
Days
Class 2
Risk

K951648 is an FDA 510(k) clearance for the MIST ENDOSCOPIC NEEDLES. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Mist, Inc. (Great Neck, US). The FDA issued a Cleared decision on May 12, 1995 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 Mist, Inc. devices

Submission Details

510(k) Number K951648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1995
Decision Date May 12, 1995
Days to Decision 32 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 130d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FBK Endoscopic Injection Needle, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue.
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FBK Endoscopic Injection Needle, Gastroenterology-urology

All 31
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K951648.
ENTERYX INJECTION CATHETER
K042882 · Boston Scientific Corp · Nov 2004
NEEDLE CATHETER
K961846 · Boston Scientific Corp · Jul 1996
INJECTION NEEDLE
K953338 · Boston Scientific Corp · Aug 1995
KARL STORZ ADULT AND PEDIATRIC VISCOUS FLUID INJECTION SETS
K950976 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
BARD ENDOSCOPIC INJECTION SYSTEM
K933815 · C.R. Bard, Inc. · Dec 1993