Cleared Traditional

K923176 - SURGICAL INSTRUMENT KIT, DISPOSABLE

K923176 is an FDA 510(k) clearance for SURGICAL INSTRUMENT KIT, manufactured by Ulti-Med Intl., Inc.. The device is a Class 1 General & Plastic Surgery device with product code KDD cleared through the Traditional 510(k) pathway after a 370-day FDA review.

K923176 · Ulti-Med Intl., Inc. · General & Plastic Surgery device
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Jun 1993
Decision
370d
Days
Class 1
Risk

K923176 is an FDA 510(k) clearance for the SURGICAL INSTRUMENT KIT, DISPOSABLE. Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by Ulti-Med Intl., Inc. (Glendale Hts., US). The FDA issued a Cleared decision on June 17, 1993 after a review of 370 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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. Elevated predicate reliance profile. 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 Ulti-Med Intl., Inc. devices

FDA 510(k) Submission Details - K923176

510(k) Number K923176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1992
Decision Date June 17, 1993
Days to Decision 370 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
255d slower than avg
Panel avg: 115d · This submission: 370d
Pathway characteristics
Predicate-based equivalence.

KDD Device Classification - Class 1, General Controls

Product Code KDD Kit, Surgical Instrument, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - KDD Kit, Surgical Instrument, Disposable

All 30
Devices cleared under the same product code (KDD) and FDA review panel - the closest regulatory comparables to K923176.
NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS
K971317 · National Healthcare Mfg. Corp. · May 1997
DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY
K960456 · Denver Biomaterials, Inc. · Apr 1996
SUTURE SET OR LACERATION TRAYS (PACKS)
K932219 · Associated Medical Products Co. · Jul 1993
DEXIDE LAPAROSCOPIC KITS
K924117 · Dexide, Inc. · Mar 1993
SURGICAL INSTRUMENT KIT, DISPOSABLE
K920989 · Ulti-Med Intl., Inc. · Oct 1992
GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB
K920516 · Trinity Laboratories, Inc. · Apr 1992