Cleared Traditional

K070783 - SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR

K070783 is an FDA 510(k) clearance for SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR, manufactured by Sopro. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K070783 · Sopro · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
267d
Days
Class 2
Risk

K070783 is an FDA 510(k) clearance for the SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Sopro (Mt. Laurel, US). The FDA issued a Cleared decision on December 13, 2007 after a review of 267 days - an extended review cycle.

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: 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 Sopro devices

FDA 510(k) Submission Details - K070783

510(k) Number K070783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2007
Decision Date December 13, 2007
Days to Decision 267 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 160d · This submission: 267d
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 83
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K070783.
HIGH FLOW INSUFFLATION UNIT UHI-4
K110294 · Olympus Medical Systems Corporation · Nov 2011
MEDLINE PNEUMOPERITONEUM NEEDLE
K111955 · Medline Industries, Inc. · Nov 2011
KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
K080852 · KARL STORZ Endoscopy-America, Inc. · Mar 2009
FLO-ASSISTANT
K041560 · Northgate Technologies, Inc. · Sep 2004
MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215
K033614 · Northgate Technologies, Inc. · Jul 2004
40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0
K022052 · Northgate Technologies, Inc. · Jan 2003