Cleared Traditional

K936011 - INVAMED REUSABLE LAPAROSCOPIC TROCAR SYSTEM

K936011 is an FDA 510(k) clearance for INVAMED REUSABLE LAPAROSCOPIC TROCAR SYSTEM, manufactured by Invamed, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K936011 · Invamed, Inc. · Obstetrics & Gynecology device
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Sep 1994
Decision
279d
Days
Class 2
Risk

K936011 is an FDA 510(k) clearance for the INVAMED REUSABLE LAPAROSCOPIC TROCAR SYSTEM. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Invamed, Inc. (San Antonio, US). The FDA issued a Cleared decision on September 21, 1994 after a review of 279 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 Invamed, Inc. devices

FDA 510(k) Submission Details - K936011

510(k) Number K936011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1993
Decision Date September 21, 1994
Days to Decision 279 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
119d slower than avg
Panel avg: 160d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

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 228
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K936011.
INSUFFLATOR TUBING WITH FILTER
K943508 · Stryker Endoscopy · Nov 1994
IMAGYN LAPAROSCOPIC INSTRUMENTS
K944129 · Imagyn Medical, Inc. · Oct 1994
ZEISS OPMI L STEREO-LAPAROSCOPE
K931478 · Carl Zeiss, Inc. · Sep 1994
SURGIMAT
K926259 · W.O.M. World of Medicine GmbH · Sep 1994
SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE
K936071 · Smith & Nephew Dyonics, Inc. · Aug 1994
VIDEO ENDOSCOPE-RIGID MODIFICATION
K921294 · Medical Dynamics, Inc. · Jul 1994