Cleared Traditional

K983925 - ENDOPATH ULTRA VERESS NEEDLE

K983925 is an FDA 510(k) clearance for ENDOPATH ULTRA VERESS NEEDLE, manufactured by Ethicon Endo-Surgery, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K983925 · Ethicon Endo-Surgery, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
90d
Days
Class 2
Risk

K983925 is an FDA 510(k) clearance for the ENDOPATH ULTRA VERESS NEEDLE. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on February 3, 1999 after a review of 90 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 Ethicon Endo-Surgery, Inc. devices

FDA 510(k) Submission Details - K983925

510(k) Number K983925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1998
Decision Date February 03, 1999
Days to Decision 90 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
70d faster than avg
Panel avg: 160d · This submission: 90d
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 95
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K983925.
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
CO2 GAS WARMING UNIT (6-800-00)
K972675 · Northgate Technologies, Inc. · Sep 1998
OMNIFLATOR 6630(6-630-00)
K973447 · Northgate Technologies, Inc. · Sep 1998
LAPARO CO2-PNEU (AND WITH VIDEO MONITORING)
K981334 · Richard Wolf Medical Instruments Corp. · Sep 1998