Cleared Traditional

K904638 - TROCAR DISPOSABLE

K904638 is an FDA 510(k) clearance for TROCAR DISPOSABLE, manufactured by L.A.S.E.R., Inc.. The device is a Class 2 General & Plastic Surgery device with product code FBQ cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K904638 · L.A.S.E.R., Inc. · General & Plastic Surgery device
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Feb 1991
Decision
133d
Days
Class 2
Risk

K904638 is an FDA 510(k) clearance for the TROCAR DISPOSABLE. Classified as Trocar, Gastro-urology (product code FBQ), Class II - Special Controls.

Submitted by L.A.S.E.R., Inc. (Tomball, US). The FDA issued a Cleared decision on February 21, 1991 after a review of 133 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.5090 - 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 L.A.S.E.R., Inc. devices

FDA 510(k) Submission Details - K904638

510(k) Number K904638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1990
Decision Date February 21, 1991
Days to Decision 133 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 115d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FBQ Device Classification - Class 2, Special Controls

Product Code FBQ Trocar, Gastro-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5090
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 - FBQ Trocar, Gastro-urology

Devices cleared under the same product code (FBQ) and FDA review panel - the closest regulatory comparables to K904638.
SABRE BT BLUNT0TIP SURGICAL TROCAR
K980804 · Endoscopic Concepts, Inc. · Apr 1998
AUTO SUTURE MODIFIED GRIP
K942885 · United States Surgical, A Division of Tyco Healthc · Aug 1994
AESCULAP TROCAR INSTRUMENT SET
K934724 · Aesculap, Inc. · Dec 1993
AUTO SUTURE SURGIPORT SPIRAL SLEEVE
K900123 · United States Surgical, A Division of Tyco Healthc · Apr 1990