Cleared Traditional

K883338 - SURGICAL SEALANT APPLICATOR

K883338 is an FDA 510(k) clearance for SURGICAL SEALANT APPLICATOR, 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 14-day FDA review.

K883338 · Micromedics, Inc. · General Hospital
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Aug 1988
Decision
14d
Days
Class 1
Risk

K883338 is an FDA 510(k) clearance for the SURGICAL SEALANT APPLICATOR. Classified as Syringe, Irrigating (non Dental) (product code KYZ), Class I - General Controls.

Submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on August 23, 1988 after a review of 14 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K883338

510(k) Number K883338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1988
Decision Date August 23, 1988
Days to Decision 14 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
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 40
Devices cleared under the same product code (KYZ) and FDA review panel - the closest regulatory comparables to K883338.
EAR IRRIGATION SET 101 (EARIGATOR)
K884786 · Physicians Supply Co. · Apr 1989
JOHNSON & JOHNSON STERILE SPRAY TIP SYRINGE
K884749 · Johnson & Johnson Patient Care, Inc. · Dec 1988
IRRIGATION KIT
K883506 · L H M Ent., Inc. · Dec 1988
SURGICAL SEALANT DISPENSER (SSD)
K881020 · Micromedics, Inc. · Mar 1988
CLEAN-FLUSH
K830572 · Burron Medical Products, Inc. · Mar 1983
SYRINGE IRRIGATING
K821530 · Medcare Disp Products, Inc. · May 1982
K883338 · SURGICAL SEALANT APPLICATOR
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