Cleared Traditional

K844628 - V. MUELLER PHEUMO-INTESTINAL INSTRUMENT...

K844628 is the FDA 510(k) clearance for V. MUELLER PHEUMO-INTESTINAL INSTRUMENT... by American V. Mueller. It is a Class 2 General & Plastic Surgery device (product code GAG) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K844628 · American V. Mueller · General & Plastic Surgery device
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Dec 1984
Decision
17d
Days
Class 2
Risk

K844628 is an FDA 510(k) clearance for the V. MUELLER PHEUMO-INTESTINAL INSTRUMENT SET. Classified as Stapler, Surgical (product code GAG), Class II - Special Controls.

Submitted by American V. Mueller (Chicago, US). The FDA issued a Cleared decision on December 14, 1984 after a review of 17 days - a notably fast clearance cycle.

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: 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 American V. Mueller devices

Submission Details

510(k) Number K844628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1984
Decision Date December 14, 1984
Days to Decision 17 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 30
Devices cleared under the same product code (GAG) and FDA review panel - the closest regulatory comparables to K844628.
PROXIMATE LINEAR CUTTER THICK TISSUE INST.
K892927 · Ethicon, Inc. · May 1989
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APPOSE ULTRA DISPOS. SKIN STAPLER W/AUTO RELEASE
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K840177 · Davis & Geck, Inc. · Mar 1984
APPOSE DISPOS. SKIN STAPLER W/AUTO
K840178 · Davis & Geck, Inc. · Mar 1984
PROXIMATE DISPOSABLE SKIN STAPLERS
K820811 · Ethicon, Inc. · Aug 1982