Cleared Special

K000048 - SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1

K000048 is an FDA 510(k) clearance for SEALOUETTE FIBRIN SEALANT EXTENDED DROP..., manufactured by Biosurgical Corp.. The device is a Class 2 General Hospital device with product code FMF cleared through the Special 510(k) pathway after a 24-day FDA review.

K000048 · Biosurgical Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
24d
Days
Class 2
Risk

K000048 is an FDA 510(k) clearance for the SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Biosurgical Corp. (Pleasanton, US). The FDA issued a Cleared decision on January 31, 2000 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K000048

510(k) Number K000048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2000
Decision Date January 31, 2000
Days to Decision 24 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 129d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

FMF Device Classification - Class 2, Special Controls

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 641
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K000048.
PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE
K993017 · Shinchang Medical Co., Ltd. · Feb 2000
VEIN ENTRY INDICATOR DEVICE (VEID)
K993995 · Vascular Technologies , Ltd. · Feb 2000
NIPRO INSULIN SYRINGE
K000144 · Nipro Medical Corp. · Feb 2000
VACLOK SYRINGE
K994253 · Merit Medical Systems, Inc. · Jan 2000
DISETRONIC PEN P100
K993666 · Disetronic Medical Systems · Nov 1999
SEALOUETTE FIBRIN SEALANT APPLICATOR
K992351 · Biosurgical Corp. · Oct 1999
K000048 · SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1
Download PDF FDA Summary Biosurgical Corp.