Cleared Traditional

K945202 - ENDOPATH ENDOSCOPIC RELOADABLE LINEAR C...

K945202 is the FDA 510(k) clearance for ENDOPATH ENDOSCOPIC RELOADABLE LINEAR C... by Ethicon Endo-Surgery, Inc.. It is a Class 2 Gastroenterology & Urology device (product code OCW) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K945202 · Ethicon Endo-Surgery, Inc. · Gastroenterology & Urology device
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Jan 1995
Decision
86d
Days
Class 2
Risk

K945202 is an FDA 510(k) clearance for the ENDOPATH ENDOSCOPIC RELOADABLE LINEAR CUTTER WITH SAFETY LOC-OUT AND RELOADIN.... Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on January 19, 1995 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 Ethicon Endo-Surgery, Inc. devices

Submission Details

510(k) Number K945202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1994
Decision Date January 19, 1995
Days to Decision 86 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 130d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OCW Endoscopic Tissue Approximation Device

All 33
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K945202.
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
DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER
K944435 · Deroyal Industries, Inc. · Nov 1994
MODIFIED ENDOPATH ILS
K940967 · Ethicon Endo-Surgery, Inc. · May 1994
ENDOSCOPIC ARTICULATING MULTI-FEED STAPLER WITH RELOAD UNIT
K935756 · Ethicon Endo-Surgery, Inc. · Apr 1994