Cleared Traditional

INSUFFLATION TUBING STERILE AND NON-STERILE (K935639) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K935639 · Charles Polo & Co., Inc. · Obstetrics & Gynecology device
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Mar 1994
Decision
114d
Days
Class 2
Risk

K935639 is an FDA 510(k) clearance for the INSUFFLATION TUBING STERILE AND NON-STERILE. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Charles Polo & Co., Inc. (Garden Grove, US). The FDA issued a Cleared decision on March 17, 1994 after a review of 114 days - within the typical 510(k) review window.

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 Charles Polo & Co., Inc. devices

Submission Details

510(k) Number K935639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1993
Decision Date March 17, 1994
Days to Decision 114 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
46d faster than avg
Panel avg: 160d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 176
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