Cleared Traditional

K951773 - PODOSPRAY DRILL SYSTEM

K951773 is an FDA 510(k) clearance for PODOSPRAY DRILL SYSTEM, manufactured by Darco Intl., Inc.. The device is a Class 1 General & Plastic Surgery device with product code GEY cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K951773 · Darco Intl., Inc. · General & Plastic Surgery device
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Oct 1995
Decision
192d
Days
Class 1
Risk

K951773 is an FDA 510(k) clearance for the PODOSPRAY DRILL SYSTEM. Classified as Motor, Surgical Instrument, Ac-powered (product code GEY), Class I - General Controls.

Submitted by Darco Intl., Inc. (Washington, US). The FDA issued a Cleared decision on October 26, 1995 after a review of 192 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - 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 Darco Intl., Inc. devices

FDA 510(k) Submission Details - K951773

510(k) Number K951773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1995
Decision Date October 26, 1995
Days to Decision 192 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 115d · This submission: 192d
Pathway characteristics
Predicate-based equivalence.

GEY Device Classification - Class 1, General Controls

Product Code GEY Motor, Surgical Instrument, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GEY Motor, Surgical Instrument, Ac-powered

All 26
Devices cleared under the same product code (GEY) and FDA review panel - the closest regulatory comparables to K951773.
SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM
K962789 · Smith & Nephew Endoscopy, Inc. · Aug 1996
BONE & MARROW COLLECTION SYSTEM
K961901 · Biomedical Ent., Inc. · Aug 1996
SURGIMOTOR
K954470 · W.O.M. World of Medicine GmbH · Dec 1995
KARL STORZ DRILL
K952008 · KARL STORZ Endoscopy-America, Inc. · Jul 1995
3M MAXI-DRIVER II ELECTRIC SYSTEM
K951118 · 3M Company · Jul 1995
AUTO LUBE SYSTEM
K940535 · The Anspach Effort, Inc. · Mar 1994