Cleared Traditional

K873598 - LASER LAPAROSCOPY SET

K873598 is an FDA 510(k) clearance for LASER LAPAROSCOPY SET, manufactured by Cuda Products Co.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K873598 · Cuda Products Co. · Obstetrics & Gynecology device
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Jan 1988
Decision
138d
Days
Class 2
Risk

K873598 is an FDA 510(k) clearance for the LASER LAPAROSCOPY SET. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Cuda Products Co. (Jacksonville, US). The FDA issued a Cleared decision on January 20, 1988 after a review of 138 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K873598

510(k) Number K873598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1987
Decision Date January 20, 1988
Days to Decision 138 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 161d · This submission: 138d
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 337
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K873598.
NEZHAT IRRIGATION PUMP SYSTEM
K880763 · Cabot Medical Corp. · May 1988
CO2 RIGID LASER ENDOSCOPE PROBE SERIES 792/LAPARO
K881010 · Sharplan Lasers, Inc. · Apr 1988
CABOT FIBER LASER PROBE
K873115 · Cabot Medical Corp. · Jan 1988
ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVE
K860192 · Endotherapeutics · Mar 1986
TRITON LAPAROSCOPIC COAGULATOR INSUFFLATOR & LAVAG
K852680 · Multigon Industries, Inc. · Dec 1985
DOUBLE PUNCTURE INSTRUMENTS
K852901 · L.A.S.E.R., Inc. · Oct 1985
K873598 · LASER LAPAROSCOPY SET
Download PDF Cuda Products Co.