Cleared Traditional

K922420 - CONTINUOUS FLOW HYSTERO-RESECTOSCOPE

K922420 is the FDA 510(k) clearance for CONTINUOUS FLOW HYSTERO-RESECTOSCOPE by Linvatec Corp.. It is a Class 2 Obstetrics & Gynecology device (product code HIH) cleared through the Traditional 510(k) pathway after a 754-day FDA review.

K922420 · Linvatec Corp. · Obstetrics & Gynecology device
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Jun 1994
Decision
754d
Days
Class 2
Risk

K922420 is an FDA 510(k) clearance for the CONTINUOUS FLOW HYSTERO-RESECTOSCOPE. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on June 14, 1994 after a review of 754 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1690 - 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 Linvatec Corp. devices

Submission Details

510(k) Number K922420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1992
Decision Date June 14, 1994
Days to Decision 754 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
594d slower than avg
Panel avg: 160d · This submission: 754d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIH Hysteroscope (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1690
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 - HIH Hysteroscope (and Accessories)

All 106
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K922420.
HAND EXTRACTOR HECTOR
K953109 · Karl Storz Endoscopy · Aug 1995
A4722 OLYMPUS OPTICAL OBTURATOR
K950055 · Olympus America, Inc. · Feb 1995
OLYMPUS 5FR SEMI-RIGID SCISSORS FOR OB/GYN
K950036 · Olympus America, Inc. · Feb 1995
HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES
K931764 · Olympus Corp. · Jun 1994
CABOT MEDICAL UTERINE RESECTOSCOPE
K924631 · Cabot Medical Corp. · May 1994
RESECTOSCOPE SHEATH
K931994 · Olympus Corp. · Feb 1994