Cleared Traditional

MULTI HI-FLO PNEU, WISAP #7080 (K011510) - FDA 510(k) Clearance

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

K011510 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · Obstetrics & Gynecology device
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Apr 2002
Decision
321d
Days
Class 2
Risk

K011510 is an FDA 510(k) clearance for the MULTI HI-FLO PNEU, WISAP #7080. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh (Sauerlach, DE). The FDA issued a Cleared decision on April 2, 2002 after a review of 321 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh devices

Submission Details

510(k) Number K011510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2001
Decision Date April 02, 2002
Days to Decision 321 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
161d slower than avg
Panel avg: 160d · This submission: 321d
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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