Cleared Traditional

K932020 - ENTREE BLUNT TIP TROCAR AND ADAPTER

K932020 is an FDA 510(k) clearance for ENTREE BLUNT TIP TROCAR AND ADAPTER, manufactured by Core Dynamics, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K932020 · Core Dynamics, Inc. · Obstetrics & Gynecology device
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Jan 1994
Decision
263d
Days
Class 2
Risk

K932020 is an FDA 510(k) clearance for the ENTREE BLUNT TIP TROCAR AND ADAPTER. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Core Dynamics, Inc. (Jacksonville, US). The FDA issued a Cleared decision on January 11, 1994 after a review of 263 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 Core Dynamics, Inc. devices

FDA 510(k) Submission Details - K932020

510(k) Number K932020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1993
Decision Date January 11, 1994
Days to Decision 263 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
103d slower than avg
Panel avg: 160d · This submission: 263d
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 166
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K932020.
RETRACTORS AND SCRAPER
K933008 · Baxter Healthcare Corp · Mar 1994
NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURES
K932634 · Marlo Surgical Technology · Feb 1994
PRIMUS INSULATED FORCEPS
K932832 · Marlo Surgical Technology · Feb 1994
JARIT SURGICAL INSTRUMENTS
K932072 · Medical Device Inspection Co., Inc. · Jan 1994
TROCAR STABILITY THREAD
K923568 · Applied Medical Resources · Dec 1993
TROCAR W/ BLUNT TIP OBTURATOR
K923636 · Applied Medical Resources · Nov 1993