Cleared Traditional

K951546 - ENDOPATH AND PROXIMATE LINEAR CUTTERS AND STAPLERS

K951546 is an FDA 510(k) clearance for ENDOPATH AND PROXIMATE LINEAR CUTTERS A..., manufactured by Ethicon Endo-Surgery, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K951546 · Ethicon Endo-Surgery, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
82d
Days
Class 2
Risk

K951546 is an FDA 510(k) clearance for the ENDOPATH AND PROXIMATE LINEAR CUTTERS AND STAPLERS. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on June 21, 1995 after a review of 82 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.

FDA 510(k) Submission Details - K951546

510(k) Number K951546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1995
Decision Date June 21, 1995
Days to Decision 82 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
33d faster than avg
Panel avg: 115d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

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 1400
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K951546.
ETHICON ARTHROSCOPIC KNOT PUSHER
K952814 · Ethicon, Inc. · Jul 1995
COMBINATION CAMERA/LIGHT SOURCE
K951386 · M.P. Video, Inc. · Jun 1995
SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A CANNULA
K951878 · General Surgical Innovations · Jun 1995
LAPAROSCOPIC SURGERY INSTRUMENTS
K932033 · Medline · Jun 1995
WOODBINE/SOLOS VCM-3, HIGH RESOLUTION ONE-CHIP SURGICAL CAMERA
K951522 · Woodbine Optical Corp. · Jun 1995
ASLAN LAPRETRACT
K952264 · Aslan Medical Technologies, Ltd. · Jun 1995
K951546 · ENDOPATH AND PROXIMATE LINEAR CUTTERS AND STAPLERS
Download PDF FDA Summary Ethicon Endo-Surgery,…