Cleared Traditional

K930933 - ENDOPATH ENDOSCOPIC SURGICAL INSTRUMENTS

K930933 is the FDA 510(k) clearance for ENDOPATH ENDOSCOPIC SURGICAL INSTRUMENTS by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K930933 · Ethicon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
119d
Days
Class 2
Risk

K930933 is an FDA 510(k) clearance for the ENDOPATH ENDOSCOPIC SURGICAL INSTRUMENTS. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Ethicon, Inc. (Cincinnati, US). The FDA issued a Cleared decision on June 22, 1993 after a review of 119 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Ethicon, Inc. devices

Submission Details

510(k) Number K930933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1993
Decision Date June 22, 1993
Days to Decision 119 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
4d slower than avg
Panel avg: 115d · This submission: 119d
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 K930933.
ENDOPATH ENDOSCOPIC TISSUE RETRACTOR
K924916 · Ethicon Endo-Surgery, Inc. · Jun 1993
KARL STORZ 495N SERIES FIBER OPTIC LIGHT CABLES
K931018 · KARL STORZ Endoscopy-America, Inc. · Jun 1993
SURGICAL MESH DELIVERY SYSTEM, GENERAL SURGERY
K930147 · Davol, Inc. · Jun 1993
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