Cleared Traditional

K932282 - ENDOPATH II DISPOSABLE SURGICAL TROCAR ...

K932282 is the FDA 510(k) clearance for ENDOPATH II DISPOSABLE SURGICAL TROCAR ... by Ethicon Endo-Surgery, Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K932282 · Ethicon Endo-Surgery, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jun 1993
Decision
41d
Days
Class 2
Risk

K932282 is an FDA 510(k) clearance for the ENDOPATH II DISPOSABLE SURGICAL TROCAR & SLEEVE. 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 22, 1993 after a review of 41 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

Submission Details

510(k) Number K932282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1993
Decision Date June 22, 1993
Days to Decision 41 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
74d faster than avg
Panel avg: 115d · This submission: 41d
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 508
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K932282.
ENDOPATH DISPOSABLE FLEXIBLE SURGICAL CANNULA
K931111 · Ethicon Endo-Surgery, Inc. · Jun 1993
ENDOPATH* DISPOSABLE INTRODUCER
K931237 · Ethicon, Inc. · Jun 1993
ENDOPATH DISPOSABLE KNOT PUSHER
K931238 · Ethicon, Inc. · Jun 1993
PRE-TIED LOOP SUTURE CANNULA
K925914 · Ethicon, Inc. · May 1993
GUIDE WIRE FOR LAPOROSCOPIC USE
K926214 · Terumo Medical Corp. · Apr 1993
AUTO SUTURE DILATING CANNULA
K931337 · United States Surgical, A Division of Tyco Healthc · Apr 1993