Cleared Traditional

K960562 - GLEESON FLO VAC & SELECTONE S/I CANNULA...

K960562 is an FDA 510(k) clearance for GLEESON FLO VAC & SELECTONE S/I CANNULA..., manufactured by Conmedcorp. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K960562 · Conmedcorp · General & Plastic Surgery device
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Apr 1996
Decision
77d
Days
Class 2
Risk

K960562 is an FDA 510(k) clearance for the GLEESON FLO VAC & SELECTONE S/I CANNULAE MODEL 60-6001, 6002, 6005. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Conmedcorp (Dayton, US). The FDA issued a Cleared decision on April 26, 1996 after a review of 77 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 Conmedcorp devices

FDA 510(k) Submission Details - K960562

510(k) Number K960562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1996
Decision Date April 26, 1996
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
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 803
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K960562.
HYDRO-FLEX LI LAPAROSCOPIC IRRIGATION SYSTEM
K961224 · Davol Inc., Sub. C. R. Bard, Inc. · May 1996
HYDRO-SURG LAPAROSCOPIC IRRIGATON MODELS 0026000. 0026010
K961492 · Davol Inc., Sub. C. R. Bard, Inc. · May 1996
AESOP SYSTEM AND ACCESSORIES
K960655 · Computer Motion, Inc. · May 1996
MODIFIED HAND INSTRUMENT DEVICES
K960748 · United States Surgical, A Division of Tyco Healthc · Apr 1996
TROGARD TROCAR DIALATING TROCAR SYSTEM
K961175 · Conmedcorp · Apr 1996
ENDOSCOPIC ACCESS DEVICE
K960232 · Applied Medical Technologies · Mar 1996