Cleared Traditional

K940371 - SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP

K940371 is an FDA 510(k) clearance for SURGICAL SEALANT APPLICATOR TIP ENDOSCO..., manufactured by Micromedics, Inc.. The device is a Class 1 General Hospital device with product code KYZ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K940371 · Micromedics, Inc. · General Hospital
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Apr 1994
Decision
90d
Days
Class 1
Risk

K940371 is an FDA 510(k) clearance for the SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP. Classified as Syringe, Irrigating (non Dental) (product code KYZ), Class I - General Controls.

Submitted by Micromedics, Inc. (Eagan, US). The FDA issued a Cleared decision on April 6, 1994 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6960 - the FDA general hospital 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Micromedics, Inc. devices

FDA 510(k) Submission Details - K940371

510(k) Number K940371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1994
Decision Date April 06, 1994
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

KYZ Device Classification - Class 1, General Controls

Product Code KYZ Syringe, Irrigating (non Dental)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6960
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 - KYZ Syringe, Irrigating (non Dental)

All 24
Devices cleared under the same product code (KYZ) and FDA review panel - the closest regulatory comparables to K940371.
CPR IRRIGATION TRAY
K960212 · Custom Pack Reliability · Apr 1996
REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION
K952406 · Contour Fabricators of Florida, Inc. · Aug 1995
REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER
K952407 · Contour Fabricators of Florida, Inc. · Aug 1995
WELCH ALLYN EARCLEANER
K931946 · Welch Allyn, Inc. · Jul 1993
IRRIGATION TRAY W/ BULB SYRINGE
K924809 · Customed, Inc. · Jun 1993
SPLASH GUARD
K905173 · E.M. Adams · Apr 1991