Cleared Traditional

K864378 - CO2 LASER MICROMANIPULATOR

K864378 is the FDA 510(k) clearance for CO2 LASER MICROMANIPULATOR by Transamerican Technologies Intl.. It is a Class 2 Obstetrics & Gynecology device (product code HHR) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K864378 · Transamerican Technologies Intl. · Obstetrics & Gynecology device
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Mar 1987
Decision
120d
Days
Class 2
Risk

K864378 is an FDA 510(k) clearance for the CO2 LASER MICROMANIPULATOR. Classified as Laser, Surgical, Gynecologic (product code HHR), Class II - Special Controls.

Submitted by Transamerican Technologies Intl. (Lafayette, US). The FDA issued a Cleared decision on March 5, 1987 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4550 - the FDA obstetrics and gynecology 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Transamerican Technologies Intl. devices

Submission Details

510(k) Number K864378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1986
Decision Date March 05, 1987
Days to Decision 120 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 160d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HHR Laser, Surgical, Gynecologic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4550
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HHR Laser, Surgical, Gynecologic

All 16
Devices cleared under the same product code (HHR) and FDA review panel - the closest regulatory comparables to K864378.
MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE
K871579 · Sharplan Lasers, Inc. · Nov 1987
CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA
K872253 · Surgical Laser Technologies, Inc. · Oct 1987
MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI.
K871220 · Cooper Lasersonics, Inc. · Jul 1987
OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN
K863221 · Laserscope · Mar 1987
MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA
K863361 · Cooper Lasersonics, Inc. · Nov 1986
SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE
K862861 · Directed Energy, Inc. · Oct 1986