Cleared Traditional

K163320 - LAP-Pump PP110

K163320 is an FDA 510(k) clearance for LAP-Pump PP110, manufactured by W.O.M. World of Medicine GmbH. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K163320 · W.O.M. World of Medicine GmbH · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Mar 2017
Decision
118d
Days
Class 2
Risk

K163320 is an FDA 510(k) clearance for the LAP-Pump PP110. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by W.O.M. World of Medicine GmbH (Berlin, DE). The FDA issued a Cleared decision on March 21, 2017 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - 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 W.O.M. World of Medicine GmbH devices

FDA 510(k) Submission Details - K163320

510(k) Number K163320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2016
Decision Date March 21, 2017
Days to Decision 118 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 160d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 - HET Laparoscope, Gynecologic (and Accessories)

All 225
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