Cleared Traditional

K954641 - ENDO-LEADER

K954641 is an FDA 510(k) clearance for ENDO-LEADER, manufactured by Microsurge, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OCW cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K954641 · Microsurge, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Dec 1995
Decision
79d
Days
Class 2
Risk

K954641 is an FDA 510(k) clearance for the ENDO-LEADER. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Microsurge, Inc. (North Attleboro, US). The FDA issued a Cleared decision on December 28, 1995 after a review of 79 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - 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 Microsurge, Inc. devices

FDA 510(k) Submission Details - K954641

510(k) Number K954641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1995
Decision Date December 28, 1995
Days to Decision 79 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCW Device Classification - Class 2, Special Controls

Product Code OCW Endoscopic Tissue Approximation Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Aid In Endoscopically Placing Sutures, Staples, Clips, And Other Fastening Tools Through Tissue.
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 - OCW Endoscopic Tissue Approximation Device

All 49
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K954641.
ENDOSCOPIC CLIP APPLIER
K962493 · Aesculap, Inc. · Sep 1996
ENDOPATH ETS LINEAR/ETS-FLEX ARTICULATING LINEAR ENDOSCOPIC CUTTER
K961390 · Ethicon Endo-Surgery, Inc. · Jun 1996
ENDOSCOPIC NEEDLE DRIVER
K960011 · United States Surgical, A Division of Tyco Healthc · Feb 1996
KOH MICRO-SUTURING INSTRUMENTS
K955479 · KARL STORZ Endoscopy-America, Inc. · Dec 1995
ENDOPATH ENDOSCOPIC RELOADABLE LINEAR CUTTER WITH SAFETY LOC-OUT AND RELOADING UNIT
K945202 · Ethicon Endo-Surgery, Inc. · Jan 1995
ORIGIN TACKER SYSTEM
K944415 · Origin Medsystems, Inc. · Nov 1994