Cleared Traditional

K923636 - TROCAR W/ BLUNT TIP OBTURATOR

K923636 is an FDA 510(k) clearance for TROCAR W/ BLUNT TIP OBTURATOR, manufactured by Applied Medical Resources. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 472-day FDA review.

K923636 · Applied Medical Resources · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Nov 1993
Decision
472d
Days
Class 2
Risk

K923636 is an FDA 510(k) clearance for the TROCAR W/ BLUNT TIP OBTURATOR. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on November 5, 1993 after a review of 472 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Applied Medical Resources devices

FDA 510(k) Submission Details - K923636

510(k) Number K923636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1992
Decision Date November 05, 1993
Days to Decision 472 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
312d slower than avg
Panel avg: 160d · This submission: 472d
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 177
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K923636.
ENTREE BLUNT TIP TROCAR AND ADAPTER
K932020 · Core Dynamics, Inc. · Jan 1994
JARIT SURGICAL INSTRUMENTS
K932072 · Medical Device Inspection Co., Inc. · Jan 1994
TROCAR STABILITY THREAD
K923568 · Applied Medical Resources · Dec 1993
URESIL LAPAROSCOPIC RETRACTOR
K921417 · Uresil Corp. · Oct 1993
VIDEO ENDOSCOPE SYSTEM
K922418 · Baxter Healthcare Corp · Jul 1993
DAVOL LAPAROSCOPIC DISSECTORS
K920234 · C.R. Bard, Inc. · Feb 1993