Cleared Traditional

MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES (K992480) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K992480 · Medifix, Inc. · Obstetrics & Gynecology device
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Sep 1999
Decision
59d
Days
Class 2
Risk

K992480 is an FDA 510(k) clearance for the MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Medifix, Inc. (Morton Grove, US). The FDA issued a Cleared decision on September 23, 1999 after a review of 59 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medifix, Inc. devices

Submission Details

510(k) Number K992480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1999
Decision Date September 23, 1999
Days to Decision 59 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
101d faster than avg
Panel avg: 160d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 96
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K992480.
MINI FIBER ENDOSCOPES
K003417 · Richard Wolf Medical Instruments Corp. · Apr 2001
TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM
K003164 · Richard Wolf Medical Instruments Corp. · Jan 2001
GYNECARE LAPAROSCOPIC MORCELLATOR
K993801 · Ethicon, Inc. · Feb 2000
DCI ENDOSCOPE
K990004 · KARL STORZ Endoscopy-America, Inc. · Apr 1999
SMITH & NEPHEW DYONICS MICROLAPAROSCOPE
K982149 · Smith & Nephew, Inc. · Sep 1998
KSEA ENDO TIP SYSTEM
K981130 · KARL STORZ Endoscopy-America, Inc. · Aug 1998