Cleared Traditional

K925558 - INFILTUBE

K925558 is an FDA 510(k) clearance for INFILTUBE, manufactured by Medsurg Industries, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 486-day FDA review.

K925558 · Medsurg Industries, Inc. · Obstetrics & Gynecology device
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Mar 1994
Decision
486d
Days
Class 2
Risk

K925558 is an FDA 510(k) clearance for the INFILTUBE. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Medsurg Industries, Inc. (Herndon, US). The FDA issued a Cleared decision on March 4, 1994 after a review of 486 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1730 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Medsurg Industries, Inc. devices

FDA 510(k) Submission Details - K925558

510(k) Number K925558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1992
Decision Date March 04, 1994
Days to Decision 486 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
326d slower than avg
Panel avg: 160d · This submission: 486d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIF Device Classification - Class 2, Special Controls

Product Code HIF Insufflator, Laparoscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1730
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 - HIF Insufflator, Laparoscopic

All 102
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K925558.
INSUFFLATION TUBING
K924481 · Applied Medical Resources · Mar 1994
DEROYAL SURGICAL DISPOSABLE INSUFFLATION TUBING
K934131 · Deroyal Industries, Inc. · Mar 1994
DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET
K935503 · Davol, Inc. · Mar 1994
INSUFFLATOR CONNECTING FILTER
K923194 · Procedure Products, Inc. · Oct 1993
INSUFFLATOR TUBING/FILTER KIT
K922244 · O.R. Concepts, Inc. · Sep 1993
MEDICAM 900 INSUFFLATOR WITH ACCESSORIES
K921837 · Kirschner Medical Corp. · Feb 1993