Cleared Traditional

K852680 - TRITON LAPAROSCOPIC COAGULATOR INSUFFLATOR & LAVAG

K852680 is an FDA 510(k) clearance for TRITON LAPAROSCOPIC COAGULATOR INSUFFLA..., manufactured by Multigon Industries, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K852680 · Multigon Industries, Inc. · Obstetrics & Gynecology device
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Dec 1985
Decision
181d
Days
Class 2
Risk

K852680 is an FDA 510(k) clearance for the TRITON LAPAROSCOPIC COAGULATOR INSUFFLATOR & LAVAG. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Multigon Industries, Inc. (Mt. Vernon, US). The FDA issued a Cleared decision on December 23, 1985 after a review of 181 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - 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 Multigon Industries, Inc. devices

FDA 510(k) Submission Details - K852680

510(k) Number K852680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1985
Decision Date December 23, 1985
Days to Decision 181 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
21d slower than avg
Panel avg: 160d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 - HET Laparoscope, Gynecologic (and Accessories)

All 226
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K852680.
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LASER LAPAROSCOPY SET
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KEYMED KEY LIGHT
K813133 · Keymed, Inc. · Nov 1981
CANNULA, W/SHARP OBTURATOR & VERESS NEED
K800668 · KARL STORZ Endoscopy-America, Inc. · May 1980
LAPAROSCOPY CONSOLE MODEL VIII
K772242 · Kli · Dec 1977