Cleared Traditional

AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608 (K982518) - FDA 510(k) Clearance

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

K982518 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · Obstetrics & Gynecology device
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Jan 1999
Decision
178d
Days
Class 2
Risk

K982518 is an FDA 510(k) clearance for the AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh (Sauerlach, DE). The FDA issued a Cleared decision on January 14, 1999 after a review of 178 days - an extended review cycle.

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 Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh devices

Submission Details

510(k) Number K982518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1998
Decision Date January 14, 1999
Days to Decision 178 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
18d slower than avg
Panel avg: 160d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 337
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