Cleared Traditional

SEALOUETTE FIBRIN SEALANT APPLICATOR (K992351) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K992351 · Biosurgical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
86d
Days
Class 2
Risk

K992351 is an FDA 510(k) clearance for the SEALOUETTE FIBRIN SEALANT APPLICATOR. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Biosurgical Corp. (Pleasanton, US). The FDA issued a Cleared decision on October 8, 1999 after a review of 86 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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.

View all Biosurgical Corp. devices

Submission Details

510(k) Number K992351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1999
Decision Date October 08, 1999
Days to Decision 86 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 129d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 209
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K992351.
DUPLOGRIP
K003193 · Baxter Healthcare Corp · Nov 2000
TISSOMAT AND SPRAY SET
K981089 · Baxter Healthcare Corp · Jul 2000
VACLOK SYRINGE
K994253 · Merit Medical Systems, Inc. · Jan 2000
STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)
K972728 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1998
BECTON DICKINSON SYRINGES
K980580 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1998
B-D PEN ULTRA
K981797 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1998