Cleared Traditional

K993625 - INSUFFLATION NEEDLE- 120MM, MODEL 900-200

K993625 is an FDA 510(k) clearance for INSUFFLATION NEEDLE- 120MM, manufactured by Genicon, LC. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K993625 · Genicon, LC · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
238d
Days
Class 2
Risk

K993625 is an FDA 510(k) clearance for the INSUFFLATION NEEDLE- 120MM, MODEL 900-200. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Genicon, LC (Orlando, US). The FDA issued a Cleared decision on June 20, 2000 after a review of 238 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 Genicon, LC devices

FDA 510(k) Submission Details - K993625

510(k) Number K993625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1999
Decision Date June 20, 2000
Days to Decision 238 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
78d slower than avg
Panel avg: 160d · This submission: 238d
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 K993625.
TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP
K000180 · Richard Wolf Medical Instruments Corp. · Mar 2001
TAUT-INSUFFLATION NEEDLE
K003703 · Taut, Inc. · Feb 2001
STRYKER HEATED INSUFFLATOR TUBE SET
K003792 · Stryker Corp. · Feb 2001
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
DISPOSABLE HEATING TUBING SET #7642HSES
K990662 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · Sep 1999