Cleared Traditional

K955393 - NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE

K955393 is an FDA 510(k) clearance for NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE F..., manufactured by Surgical Innovations Plc. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 412-day FDA review.

K955393 · Surgical Innovations Plc · Obstetrics & Gynecology device
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Jan 1997
Decision
412d
Days
Class 2
Risk

K955393 is an FDA 510(k) clearance for the NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Surgical Innovations Plc (Dacula, US). The FDA issued a Cleared decision on January 9, 1997 after a review of 412 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 Surgical Innovations Plc devices

FDA 510(k) Submission Details - K955393

510(k) Number K955393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1995
Decision Date January 09, 1997
Days to Decision 412 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
252d slower than avg
Panel avg: 160d · This submission: 412d
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 96
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K955393.
SURGIFLATOR-30
K973432 · W.O.M. World of Medicine GmbH · Dec 1997
KSEA CO2 ENDOFLATOR
K963423 · Karl Storz Endoscopy · May 1997
SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR
K962683 · Deknatel, Inc. · Jan 1997
SURGIFLATOR-20 PIM
K955791 · W.O.M. World of Medicine GmbH · Dec 1996
KSEA THERMOFLATOR (MODEL 26 4320 20)
K955073 · KARL STORZ Endoscopy-America, Inc. · Dec 1996
KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR
K962863 · KARL STORZ Endoscopy-America, Inc. · Nov 1996