Cleared Traditional

K913469 - ENDOPATH DISPOSABLE ENDOSCOPIC MULTIFEE...

K913469 is the FDA 510(k) clearance for ENDOPATH DISPOSABLE ENDOSCOPIC MULTIFEE... by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K913469 · Ethicon, Inc. · General & Plastic Surgery device
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Sep 1991
Decision
56d
Days
Class 2
Risk

K913469 is an FDA 510(k) clearance for the ENDOPATH DISPOSABLE ENDOSCOPIC MULTIFEED STAPLER. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on September 30, 1991 after a review of 56 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 Ethicon, Inc. devices

Submission Details

510(k) Number K913469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1991
Decision Date September 30, 1991
Days to Decision 56 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 115d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - GCJ Laparoscope, General & Plastic Surgery

All 677
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K913469.
MEDICAM LAPAROSCOPY ENDOSCOPES
K912933 · Kirschner Medical Corp. · Oct 1991
LAPAROSCOPIC BALLOON RETRACTOR
K914203 · Origin Medsystems, Inc. · Oct 1991
GRASPER, RATCHETED (5MM X 30CM)
K913991 · Northgate Technologies, Inc. · Oct 1991
ENDOSCOPE SUTURE & CARRIER
K912973 · United States Surgical, A Division of Tyco Healthc · Sep 1991
AUTO SUTURE ENDOSCOPIC FASCIA STAPLER
K912097 · United States Surgical, A Division of Tyco Healthc · Sep 1991
5MM MICROSCISSORS
K913870 · Endovations · Sep 1991