Cleared Traditional

K930399 - ORC ENDOSCOPIC INSTRUMENT HOLDER

K930399 is an FDA 510(k) clearance for ORC ENDOSCOPIC INSTRUMENT HOLDER, manufactured by O.R. Concepts, Inc.. The device is a Class 1 General & Plastic Surgery device with product code MDM cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K930399 · O.R. Concepts, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
22d
Days
Class 1
Risk

K930399 is an FDA 510(k) clearance for the ORC ENDOSCOPIC INSTRUMENT HOLDER. Classified as Instrument, Manual, Surgical, General Use (product code MDM), Class I - General Controls.

Submitted by O.R. Concepts, Inc. (Roanoke, US). The FDA issued a Cleared decision on February 17, 1993 after a review of 22 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K930399

510(k) Number K930399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1993
Decision Date February 17, 1993
Days to Decision 22 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
93d faster than avg
Panel avg: 115d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

MDM Device Classification - Class 1, General Controls

Product Code MDM Instrument, Manual, Surgical, General Use
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 - MDM Instrument, Manual, Surgical, General Use

All 43
Devices cleared under the same product code (MDM) and FDA review panel - the closest regulatory comparables to K930399.
SV 100200 - SINGLE USE ONLY - STERILE HOSPITAL KIT
K923281 · Savoy Medical Supply Co., Inc. · Mar 1993
HOSPITAL KIT EP 104
K922128 · Savoy Medical Supply Co., Inc. · Mar 1993
BREAST STABILIZER
K925874 · Bip USA, Inc. · Mar 1993
PERSONNA SAFETY SCALPEL
K924503 · American Safety Razor Co. · Feb 1993
AMERICAN BIOMED, INC. MICROSURGICAL INSTRUMENTS
K924725 · American Biomaterials Corp. · Feb 1993
CENTURION DISPOSABLE INSTRUMENTS
K923812 · Tri-State Hospital Supply Corp. · Dec 1992
K930399 · ORC ENDOSCOPIC INSTRUMENT HOLDER
Download PDF O.R. Concepts, Inc.