Cleared Traditional

K933873 - CONCEPT UNIVERSAL PUMP SYSTEM

K933873 is an FDA 510(k) clearance for CONCEPT UNIVERSAL PUMP SYSTEM, manufactured by Linvatec Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HIG cleared through the Traditional 510(k) pathway after a 507-day FDA review.

K933873 · Linvatec Corp. · Obstetrics & Gynecology device
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Dec 1994
Decision
507d
Days
Class 2
Risk

K933873 is an FDA 510(k) clearance for the CONCEPT UNIVERSAL PUMP SYSTEM. Classified as Insufflator, Hysteroscopic (product code HIG), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on December 29, 1994 after a review of 507 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1700 - 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 Linvatec Corp. devices

FDA 510(k) Submission Details - K933873

510(k) Number K933873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1993
Decision Date December 29, 1994
Days to Decision 507 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
347d slower than avg
Panel avg: 160d · This submission: 507d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIG Device Classification - Class 2, Special Controls

Product Code HIG Insufflator, Hysteroscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1700
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 - HIG Insufflator, Hysteroscopic

All 42
Devices cleared under the same product code (HIG) and FDA review panel - the closest regulatory comparables to K933873.
HYS-SURGIFLATOR
K924523 · W.O.M. World of Medicine GmbH · Apr 1995
THE KARL STORZ HAMOU ENDOMAT
K936231 · Karl Storz Endoscopy · Jan 1995
BARD HYSTERO-FLO II PUMP
K933384 · Davol Inc., Sub. C. R. Bard, Inc. · Dec 1994
HYSTEROMED 100
K930912 · Northgate Technologies, Inc. · Oct 1994
INSUFFLATOR TUBING KIT
K922197 · O.R. Concepts, Inc. · Sep 1993
THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR
K912498 · KARL STORZ Endoscopy-America, Inc. · Dec 1991