Cleared Traditional

K021247 - PNEUMOPERITONEUM INSUFFLATION NEEDLE

K021247 is an FDA 510(k) clearance for PNEUMOPERITONEUM INSUFFLATION NEEDLE, manufactured by Mectra Labs, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K021247 · Mectra Labs, Inc. · Obstetrics & Gynecology device
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Nov 2002
Decision
203d
Days
Class 2
Risk

K021247 is an FDA 510(k) clearance for the PNEUMOPERITONEUM INSUFFLATION NEEDLE. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Mectra Labs, Inc. (Bloomfield, US). The FDA issued a Cleared decision on November 8, 2002 after a review of 203 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.

FDA 510(k) Submission Details - K021247

510(k) Number K021247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2002
Decision Date November 08, 2002
Days to Decision 203 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
42d slower than avg
Panel avg: 161d · This submission: 203d
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 178
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K021247.
HI-FLO THERME PNEU 45, WISAP #7083, 7083V
K031014 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · Jun 2003
LAPAROSHIELD CONDITIONED INSUFFLATION SET
K030469 · Pall Medical · May 2003
40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0
K022052 · Northgate Technologies, Inc. · Jan 2003
VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES
K022318 · Vomed Volzer Medizintechnik GmbH & Co. · Sep 2002
UHI-3 HIGH FLOW INSUFFLATION UNIT
K014166 · Olympus Optical Co., Ltd. · Jun 2002
MULTI HI-FLO PNEU, WISAP #7080
K011510 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · Apr 2002
K021247 · PNEUMOPERITONEUM INSUFFLATION NEEDLE
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