Cleared Traditional

K912927 - AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE

K912927 is the FDA 510(k) clearance for AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE by Intl. Medical, Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K912927 · Intl. Medical, Inc. · General & Plastic Surgery device
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Sep 1991
Decision
78d
Days
Class 2
Risk

K912927 is an FDA 510(k) clearance for the AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Intl. Medical, Inc. (Danielson, US). The FDA issued a Cleared decision on September 19, 1991 after a review of 78 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 Intl. Medical, Inc. devices

Submission Details

510(k) Number K912927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1991
Decision Date September 19, 1991
Days to Decision 78 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
37d faster than avg
Panel avg: 115d · This submission: 78d
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 512
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K912927.
ENDOPATH DISPOSABLE ENDOSCOPIC MULTIFEED STAPLER
K913469 · Ethicon, Inc. · Sep 1991
ENDOSCOPE SUTURE & CARRIER
K912973 · United States Surgical, A Division of Tyco Healthc · Sep 1991
AUTO SUTURE ENDOSCOPIC FASCIA STAPLER
K912097 · United States Surgical, A Division of Tyco Healthc · Sep 1991
SUCTION/IRRIGATION DEVICE WITH HYDRO-DISSECTION
K911105 · United States Surgical, A Division of Tyco Healthc · Aug 1991
LAPAROSCOPIC LASER FIBER DIVERTER
K912502 · United States Endoscopy Group, Inc. · Jul 1991
PALPATATION AND MEASURING STICK
K911489 · United States Endoscopy Group, Inc. · Jul 1991