Cleared Traditional

K915854 - ENDOSCOPIC TRANSLUMINATOR

K915854 is an FDA 510(k) clearance for ENDOSCOPIC TRANSLUMINATOR, manufactured by O.R. Concepts, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K915854 · O.R. Concepts, Inc. · General & Plastic Surgery device
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Mar 1992
Decision
82d
Days
Class 2
Risk

K915854 is an FDA 510(k) clearance for the ENDOSCOPIC TRANSLUMINATOR. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by O.R. Concepts, Inc. (Roanoke, US). The FDA issued a Cleared decision on March 18, 1992 after a review of 82 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - 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 O.R. Concepts, Inc. devices

FDA 510(k) Submission Details - K915854

510(k) Number K915854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1991
Decision Date March 18, 1992
Days to Decision 82 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
33d faster than avg
Panel avg: 115d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - GCJ Laparoscope, General & Plastic Surgery

All 723
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K915854.
LAP TISSUE COLLECTION BAG
K915286 · Baxter Healthcare Corp · Apr 1992
LM15(TM), CATALOG NUMBER - 523821
K914690 · Edward Weck, Inc. · Mar 1992
ENDOPATH ENDOS LINEAR CUT W/SAF LOCK-OUT/RELOAD UN
K915099 · Ethicon, Inc. · Mar 1992
LAPAROSCOPY SCISSORS
K915544 · C.R. Bard, Inc. · Mar 1992
XENON ARC ENDOSCOPE LIGHT SOURCE
K920403 · Medical Device Inspection Co., Inc. · Feb 1992
EVACUATION KIT #7-510-14
K914861 · Northgate Technologies, Inc. · Jan 1992