Cleared Traditional

K933901 - REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER)

K933901 is an FDA 510(k) clearance for REFLEX EHS (ENDOSCOPIC HERNIA STAPLER), manufactured by Richard-Allan Medical. The device is a Class 2 General & Plastic Surgery device with product code GAG cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K933901 · Richard-Allan Medical · General & Plastic Surgery device
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Nov 1993
Decision
101d
Days
Class 2
Risk

K933901 is an FDA 510(k) clearance for the REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER). Classified as Stapler, Surgical (product code GAG), Class II - Special Controls.

Submitted by Richard-Allan Medical (Richland, US). The FDA issued a Cleared decision on November 19, 1993 after a review of 101 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4740 - 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 Richard-Allan Medical devices

FDA 510(k) Submission Details - K933901

510(k) Number K933901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1993
Decision Date November 19, 1993
Days to Decision 101 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 115d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAG Device Classification - Class 2, Special Controls

Product Code GAG Stapler, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4740
Definition A Surgical Stapler For Internal Use Is A Specialized Prescription Device Used To Deliver Compatible Staples To Internal Tissues During Surgery For Resection, Transection, And Creating Anastomoses.
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 - GAG Stapler, Surgical

All 33
Devices cleared under the same product code (GAG) and FDA review panel - the closest regulatory comparables to K933901.
ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP
K962258 · Ethicon Endo-Surgery, Inc. · Sep 1996
DEROYAL SURG DISP/REUSABLE SKIN STAPLER HANDLE/CART
K934188 · Deroyal Industries, Inc. · Mar 1994
PROXIMATE RELOADABLE ARTICULATING LINEAR STAPLER
K932476 · Ethicon Endo-Surgery, Inc. · Dec 1993
PROXIMATE LINEAR CUTTER THICK TISSUE INST.
K892927 · Ethicon, Inc. · May 1989
V. MUELLER (R) GOOSENECK CIRCULAR STAPLER
K862772 · American V. Mueller · Aug 1986
WECK LX TM SKIN STAPLER
K851258 · Edward Weck, Inc. · Jun 1985