Cleared Traditional

MODIFIED POWERED DISPOSABLE LDS SURGICAL STAPLER (K900043) - FDA 510(k) Clearance

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

K900043 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
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Feb 1990
Decision
37d
Days
Class 2
Risk

K900043 is an FDA 510(k) clearance for the MODIFIED POWERED DISPOSABLE LDS SURGICAL STAPLER. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on February 9, 1990 after a review of 37 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 United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K900043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1990
Decision Date February 09, 1990
Days to Decision 37 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 115d · This submission: 37d
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 106
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K900043.
AUTO SUTURE ENDOSCOPIC TA SURGICAL STAPLER
K910192 · United States Surgical, A Division of Tyco Healthc · Feb 1991
AUTO SUTURE(R) TA PREMIUM(TM) UROLOGY STAPLER
K905106 · United States Surgical, A Division of Tyco Healthc · Jan 1991
MODIFIED AUTO SUTURE ENDOSCOPIC GIA SURG. STAPLER*
K900129 · United States Surgical, A Division of Tyco Healthc · Feb 1990
MODIFIED PSS & PFS POWERED SKIN & FASCIA STAPLERS
K900055 · United States Surgical, A Division of Tyco Healthc · Feb 1990
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