Cleared Traditional

K971738 - ENDOPATH RESPOSABLE TROCAR SYSTEM

K971738 is an FDA 510(k) clearance for ENDOPATH RESPOSABLE TROCAR SYSTEM, 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 87-day FDA review.

K971738 · Ethicon Endo-Surgery, Inc. · General & Plastic Surgery device
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Aug 1997
Decision
87d
Days
Class 2
Risk

K971738 is an FDA 510(k) clearance for the ENDOPATH RESPOSABLE TROCAR SYSTEM. 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 August 7, 1997 after a review of 87 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 Endo-Surgery, Inc. devices

FDA 510(k) Submission Details - K971738

510(k) Number K971738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1997
Decision Date August 07, 1997
Days to Decision 87 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
28d faster than avg
Panel avg: 115d · This submission: 87d
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 858
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K971738.
SHIELDED SURGICAL TROCAR
K971475 · Ethicon Endo-Surgery, Inc. · Aug 1997
SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIES
K971850 · Smith & Nephew, Inc. · Aug 1997
MVM 3.3 MM MICROENDOSCOPE
K972504 · KARL STORZ Endoscopy-America, Inc. · Aug 1997
INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR
K965001 · Intuitive Surgical, Inc. · Jul 1997
SMITH & NEPHEW MIS INSTRUMENTS
K970949 · Smith & Nephew Endoscopy, Inc. · Apr 1997
AESOP SYSTEM AND ACCESSORIES
K963126 · Computer Motion, Inc. · Apr 1997