Cleared Traditional

K902258 - 5 MM IRRIGATION/ASPIRATION FIBER PROBE

K902258 is an FDA 510(k) clearance for 5 MM IRRIGATION/ASPIRATION FIBER PROBE, manufactured by Hgm Medical Laser Systems, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K902258 · Hgm Medical Laser Systems, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1990
Decision
121d
Days
Class 2
Risk

K902258 is an FDA 510(k) clearance for the 5 MM IRRIGATION/ASPIRATION FIBER PROBE. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Hgm Medical Laser Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 19, 1990 after a review of 121 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.

View all Hgm Medical Laser Systems, Inc. devices

FDA 510(k) Submission Details - K902258

510(k) Number K902258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1990
Decision Date September 19, 1990
Days to Decision 121 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
39d faster than avg
Panel avg: 160d · This submission: 121d
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 166
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K902258.
LAPAROSCOPIC ACCESS SHEATH SET
K903124 · Cook, Inc. · Oct 1990
LAPAROSCOPIC CATHERTER
K903187 · Cook Ob/Gyn · Oct 1990
AUTO SUTURE ENDOSCOPIC SUCTION/IRRIGATRION DEVICE
K903207 · United States Surgical, A Division of Tyco Healthc · Sep 1990
SPIRTOS COAXIAL CATHETER SET
K896524 · Cook Ob/Gyn · Sep 1990
MONOSCOPY(TM) BRAND, TROCAR REDUCER SET
K902563 · Dexide, Inc. · Sep 1990
LAPAROSCOPIC ACCESS SHEATH SET
K897064 · Cook Ob/Gyn · Feb 1990