Cleared Traditional

K890447 - HEMORRHAGE OCCLUDOR

K890447 is the FDA 510(k) clearance for HEMORRHAGE OCCLUDOR by Surgeon Surgical Instrumentation, Inc.. It is a Class 2 General & Plastic Surgery device (product code GDW) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K890447 · Surgeon Surgical Instrumentation, Inc. · General & Plastic Surgery device
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Feb 1989
Decision
27d
Days
Class 2
Risk

K890447 is an FDA 510(k) clearance for the HEMORRHAGE OCCLUDOR. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Surgeon Surgical Instrumentation, Inc. (Placentia, US). The FDA issued a Cleared decision on February 23, 1989 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - the FDA general and plastic surgery 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 Surgeon Surgical Instrumentation, Inc. devices

Submission Details

510(k) Number K890447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1989
Decision Date February 23, 1989
Days to Decision 27 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GDW Staple, Implantable

All 159
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K890447.
AUTO SUTURE(R) ENDOSCOPIC GIA(TM) SURGICAL STAPLER
K892233 · United States Surgical, A Division of Tyco Healthc · Apr 1989
TITANIUM STAPLES
K890841 · Ethicon, Inc. · Apr 1989
AUTO SUTURE ABSORBABLE FASCIA SURGICAL STAPLER*
K890270 · United States Surgical, A Division of Tyco Healthc · Mar 1989
PRECISE ILA AND ILAN SURGICAL STAPLES
K885222 · 3M Company · Feb 1989
BIOFRAGMENTABLE BOWEL ANASTOMOSIS RING
K881484 · Davis & Geck, Inc. · May 1988
RICA(TM)-RING INTEST. COMPRESS. STAPLE ANASTOM KIT
K873748 · Deknatel, Inc. · Jan 1988