Cleared Traditional

K932072 - JARIT SURGICAL INSTRUMENTS

K932072 is an FDA 510(k) clearance for JARIT SURGICAL INSTRUMENTS, manufactured by Medical Device Inspection Co., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K932072 · Medical Device Inspection Co., Inc. · Obstetrics & Gynecology device
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Jan 1994
Decision
258d
Days
Class 2
Risk

K932072 is an FDA 510(k) clearance for the JARIT SURGICAL INSTRUMENTS. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on January 11, 1994 after a review of 258 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.

FDA 510(k) Submission Details - K932072

510(k) Number K932072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1993
Decision Date January 11, 1994
Days to Decision 258 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
97d slower than avg
Panel avg: 161d · This submission: 258d
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 337
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K932072.
APOLLO CAMERA
K931136 · Life Sensing Instrument Company, Inc. · Jan 1994
NUMED DISPOSABLE ATT. NUMED HANDLE LAP. INST.
K931501 · Numed Technologies, Inc. · Jan 1994
ENTREE BLUNT TIP TROCAR AND ADAPTER
K932020 · Core Dynamics, Inc. · Jan 1994
TROCAR STABILITY THREAD
K923568 · Applied Medical Resources · Dec 1993
DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM
K921716 · American Surgical Instruments Corp. · Nov 1993
TROCAR W/ BLUNT TIP OBTURATOR
K923636 · Applied Medical Resources · Nov 1993
K932072 · JARIT SURGICAL INSTRUMENTS
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