Cleared Traditional

K930934 - ENDOPATH RELOADABLE LINEAR CUTTER

K930934 is the FDA 510(k) clearance for ENDOPATH RELOADABLE LINEAR CUTTER by Ethicon, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 381-day FDA review.

K930934 · Ethicon, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Mar 1994
Decision
381d
Days
Class 2
Risk

K930934 is an FDA 510(k) clearance for the ENDOPATH RELOADABLE LINEAR CUTTER. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Ethicon, Inc. (Cincinnati, US). The FDA issued a Cleared decision on March 11, 1994 after a review of 381 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - the FDA obstetrics and gynecology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ethicon, Inc. devices

Submission Details

510(k) Number K930934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1993
Decision Date March 11, 1994
Days to Decision 381 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
221d slower than avg
Panel avg: 160d · This submission: 381d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HET Laparoscope, Gynecologic (and Accessories)

All 150
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K930934.
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HASSON 360 SERIES ENDOSCOPIC GRASPING FORCEPS
K934451 · Cook Urological, Inc. · Mar 1994
FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE
K915857 · Olympus Corp. · Mar 1994
RETRACTORS AND SCRAPER
K933008 · Baxter Healthcare Corp · Mar 1994
TROCAR STABILITY THREAD
K923568 · Applied Medical Resources · Dec 1993
TROCAR W/ BLUNT TIP OBTURATOR
K923636 · Applied Medical Resources · Nov 1993