Cleared Traditional

K990662 - DISPOSABLE HEATING TUBING SET #7642HSES

K990662 is an FDA 510(k) clearance for DISPOSABLE HEATING TUBING SET #7642HSES, manufactured by Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K990662 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
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Sep 1999
Decision
207d
Days
Class 2
Risk

K990662 is an FDA 510(k) clearance for the DISPOSABLE HEATING TUBING SET #7642HSES. 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 September 24, 1999 after a review of 207 days - an extended review cycle.

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 Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh devices

FDA 510(k) Submission Details - K990662

510(k) Number K990662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1999
Decision Date September 24, 1999
Days to Decision 207 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 160d · This submission: 207d
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 105
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K990662.
INSUFFLATION NEEDLE- 120MM, MODEL 900-200
K993625 · Genicon, LC · Jun 2000
INSUFFLATION NEEDLE, MODEL R65-933
K000027 · A & A Medical, Inc. · Apr 2000
LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT
K991906 · Richard Wolf Medical Instruments Corp. · Nov 1999
CO2 GAS WARMER II, MODEL 6-800-00
K992381 · Northgate Technologies, Inc. · Sep 1999
OMNIFLATOR 7640 MODEL 7-640-00
K983326 · Northgate Technologies, Inc. · Feb 1999
ENDOPATH ULTRA VERESS NEEDLE
K983925 · Ethicon Endo-Surgery, Inc. · Feb 1999