Cleared Traditional

K924958 - BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKI...

K924958 is an FDA 510(k) clearance for BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKI..., manufactured by Medical Insights, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KDD cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K924958 · Medical Insights, Inc. · General & Plastic Surgery device
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Jun 1993
Decision
250d
Days
Class 1
Risk

K924958 is an FDA 510(k) clearance for the BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY. Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by Medical Insights, Inc. (Mystic, US). The FDA issued a Cleared decision on June 7, 1993 after a review of 250 days - an extended review cycle.

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. 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 Medical Insights, Inc. devices

FDA 510(k) Submission Details - K924958

510(k) Number K924958 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received September 30, 1992
Decision Date June 07, 1993
Days to Decision 250 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
135d slower than avg
Panel avg: 115d · This submission: 250d
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 20
Devices cleared under the same product code (KDD) and FDA review panel - the closest regulatory comparables to K924958.
CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES
K072814 · Covidien · Apr 2008
SUTURE SET OR LACERATION TRAYS (PACKS)
K932219 · Associated Medical Products Co. · Jul 1993
DEXIDE LAPAROSCOPIC KITS
K924117 · Dexide, Inc. · Mar 1993
GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB
K920516 · Trinity Laboratories, Inc. · Apr 1992
BAXTER PREOPERATIVE SKIN PREP TRAY W/FOAM SPONGES
K911606 · Baxter Healthcare Corp · Jul 1991
MEGA GENERAL PURPOSE INSTRUMENT KIT
K910366 · Megadyne Medical Products, Inc. · Mar 1991