Cleared Traditional

K900988 - AMCATH SUCTION-IRRIGATION TUBE

K900988 is an FDA 510(k) clearance for AMCATH SUCTION-IRRIGATION TUBE, manufactured by Intl. Medical, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K900988 · Intl. Medical, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
May 1990
Decision
66d
Days
Class 2
Risk

K900988 is an FDA 510(k) clearance for the AMCATH SUCTION-IRRIGATION TUBE. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Intl. Medical, Inc. (Danielson, US). The FDA issued a Cleared decision on May 7, 1990 after a review of 66 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K900988

510(k) Number K900988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1990
Decision Date May 07, 1990
Days to Decision 66 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
95d faster than avg
Panel avg: 161d · This submission: 66d
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 304
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K900988.
GYNESCOPE LAPAROSCOPES
K902655 · Gynescope Corp. · Jul 1990
GYNESCOPE LAPAROSCOPIC TROCARS AND SLEEVES
K902656 · Gynescope Corp. · Jun 1990
CORE DISPOSABLE TROCARS
K901407 · Core Dynamics, Inc. · Jun 1990
NEZHAT/DORSEY HYDRO DISSECTION PUMP OB-GYN USE
K896118 · American Surgical Instruments Corp. · Mar 1990
GYNECOLOGICAL INSTRUMENTATION
K895225 · Gynescope Corp. · Mar 1990
LAPAROSCOPIC ACCESS SHEATH SET
K897064 · Cook Ob/Gyn · Feb 1990
K900988 · AMCATH SUCTION-IRRIGATION TUBE
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