Cleared Traditional

K944415 - ORIGIN TACKER SYSTEM

K944415 is an FDA 510(k) clearance for ORIGIN TACKER SYSTEM, manufactured by Origin Medsystems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCW cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K944415 · Origin Medsystems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
81d
Days
Class 2
Risk

K944415 is an FDA 510(k) clearance for the ORIGIN TACKER SYSTEM. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Origin Medsystems, Inc. (Menlo Park, US). The FDA issued a Cleared decision on November 28, 1994 after a review of 81 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 Origin Medsystems, Inc. devices

FDA 510(k) Submission Details - K944415

510(k) Number K944415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1994
Decision Date November 28, 1994
Days to Decision 81 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
49d faster than avg
Panel avg: 130d · This submission: 81d
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OCW Endoscopic Tissue Approximation Device

All 37
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K944415.
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
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