Cleared Traditional

CANUSEAL (K925932) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K925932 · Lap Associates of Nashville, Ii, Inc. · General & Plastic Surgery device
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Apr 1993
Decision
151d
Days
Class 2
Risk

K925932 is an FDA 510(k) clearance for the CANUSEAL. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Lap Associates of Nashville, Ii, Inc. (Miami, US). The FDA issued a Cleared decision on April 23, 1993 after a review of 151 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Lap Associates of Nashville, Ii, Inc. devices

Submission Details

510(k) Number K925932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1992
Decision Date April 23, 1993
Days to Decision 151 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 115d · This submission: 151d
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 399
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K925932.
AUTO SUTURE DILATING CANNULA
K931337 · United States Surgical, A Division of Tyco Healthc · Apr 1993
ENDOPATH TISSUE EXTRACTION CANNULA
K930935 · Ethicon, Inc. · Apr 1993
MODIFIED AUTO SUTURE SURGIPORT PREMIUM SEAL
K925860 · United States Surgical, A Division of Tyco Healthc · Apr 1993
MODIFIED ENDOSCOPIC CLAMP
K930567 · United States Surgical, A Division of Tyco Healthc · Apr 1993
ENDOPATH INTERCEED ABSORBABLE ADHESION BARRIER
K920595 · Ethicon, Inc. · Apr 1993
AESCULAP TROCAR INSTRUMENT SET
K922797 · Aesculap, Inc. · Mar 1993