Cleared Traditional

K914377 - TROCAR

K914377 is the FDA 510(k) clearance for TROCAR by O.R. Concepts, Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K914377 · O.R. Concepts, Inc. · General & Plastic Surgery device
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Oct 1991
Decision
29d
Days
Class 2
Risk

K914377 is an FDA 510(k) clearance for the TROCAR. 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 October 30, 1991 after a review of 29 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

Submission Details

510(k) Number K914377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1991
Decision Date October 30, 1991
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 693
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K914377.
PNEUMO-SEAL(TM)
K914470 · Edward Weck, Inc. · Nov 1991
DAVOL ENDO-FLO SUCT/IRRI PROBE (FOR GEN SURGERY)
K914526 · Davol, Inc. · Nov 1991
LAPAROBAG(TM) TISSUE RETRIEVAL SYSTEM
K914547 · Baxter Healthcare Corp · Nov 1991
MONOSCOPY(TM) BRAND, ENDOBAG
K913762 · Dexide, Inc. · Oct 1991
EVACUATION/IRRIGATION/ELECROSURGICAL DEVICE
K912492 · Ethicon, Inc. · Oct 1991
MEDICAM LAPAROSCOPY ENDOSCOPES
K912933 · Kirschner Medical Corp. · Oct 1991