Cleared Traditional

K922405 - O.R.C. ADAPTER

K922405 is an FDA 510(k) clearance for O.R.C. ADAPTER, 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 85-day FDA review.

K922405 · O.R. Concepts, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
85d
Days
Class 2
Risk

K922405 is an FDA 510(k) clearance for the O.R.C. ADAPTER. 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 August 14, 1992 after a review of 85 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 - K922405

510(k) Number K922405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1992
Decision Date August 14, 1992
Days to Decision 85 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
30d faster than avg
Panel avg: 115d · This submission: 85d
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 K922405.
ENDO-GARD ELECTROSURGICAL TROCAR
K915790 · Conmedcorp · Oct 1992
AUTO SUTURE ENDOSCOPIC MINI-RETRACTOR
K920068 · United States Surgical, A Division of Tyco Healthc · Sep 1992
DAVOL LAPAROSCOPIC LOOP AND RETRIEVAL DEVICES
K922526 · Davol, Inc. · Sep 1992
INSTRUMENT, MANUAL, GENERAL SURGICAL
K922571 · Symbiosis Corp. · Aug 1992
HOOK SURGICAL INSTRUMENT
K920599 · Origin Medsystems, Inc. · Jul 1992
ENDOBAG, MODIFICATION
K921709 · Dexide, Inc. · Jul 1992