Cleared Traditional

K992480 - MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES

K992480 is an FDA 510(k) clearance for MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPA..., manufactured by Medifix, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K992480 · Medifix, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K992480

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
Combination Product No
PCCP Authorized No
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.

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 215
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K992480.
THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF
K992513 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · Mar 2000
GYNECARE LAPAROSCOPIC MORCELLATOR
K993801 · Ethicon, Inc. · Feb 2000
MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY
K990372 · Dr. Fritz GmbH · Oct 1999
LAP-WAVE 3000 (P07)
K990732 · W.O.M. World of Medicine GmbH · Jul 1999
DCI ENDOSCOPE
K990004 · KARL STORZ Endoscopy-America, Inc. · Apr 1999
BAHO AUTOCLAVABLE LAPAROSCOPE
K982276 · Microptix Int'L, LLC · Feb 1999