Cleared Traditional

K905587 - AUTO SUTURE ENDOSCOPIC LDS(TM) LIGATING...

K905587 is the FDA 510(k) clearance for AUTO SUTURE ENDOSCOPIC LDS(TM) LIGATING... by United States Surgical, A Division of Tyco Healthc. It is a Class 2 General & Plastic Surgery device (product code FZP) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K905587 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1991
Decision
34d
Days
Class 2
Risk

K905587 is an FDA 510(k) clearance for the AUTO SUTURE(R) ENDOSCOPIC LDS(TM) LIGATING DEVICE. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on January 16, 1991 after a review of 34 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - 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 K905587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1990
Decision Date January 16, 1991
Days to Decision 34 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
81d faster than avg
Panel avg: 115d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FZP Clip, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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 - FZP Clip, Implantable

All 103
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K905587.
ETHICON LIGACLIP ENDO LD APPLIER/DIVIDER
K920847 · Ethicon, Inc. · May 1992
AUTO SUTURE MODIFIED POLYMER SKIN GRAFT STAPLE
K915151 · United States Surgical, A Division of Tyco Healthc · Jan 1992
HEMOCLIP II
K911915 · Edward Weck, Inc. · Jan 1992
HEM-O-LOK(TM)
K902108 · Edward Weck, Inc. · Aug 1990
AUTO SUTURE LATCHLESS ABSORBABLE HEMOSTATIC CLIP*
K900122 · United States Surgical, A Division of Tyco Healthc · Mar 1990
AUTO SUTURE DISP. ENDOSCOPIC SURG. CLIP APPLIER
K883018 · United States Surgical, A Division of Tyco Healthc · Aug 1988