Cleared Traditional

HYSTEROSCOPES (K003802) - FDA 510(k) Clearance

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

K003802 · Global Endoscopy, Inc. · Obstetrics & Gynecology device
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Jul 2001
Decision
226d
Days
Class 2
Risk

K003802 is an FDA 510(k) clearance for the HYSTEROSCOPES. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Global Endoscopy, Inc. (Schaumburg, US). The FDA issued a Cleared decision on July 22, 2001 after a review of 226 days - an extended review cycle.

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: 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.

View all Global Endoscopy, Inc. devices

Submission Details

510(k) Number K003802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2000
Decision Date July 22, 2001
Days to Decision 226 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
66d slower than avg
Panel avg: 160d · This submission: 226d
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 76
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K003802.
IUR RECIPROCATING MORCELLATOR MODEL # 7210517
K041774 · Smith & Nephew, Inc. · Oct 2004
SMITH & NEPHEW IUR MORCELLATION SYSTEM
K031787 · Smith & Nephew, Inc. · Dec 2003
SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208
K013870 · Smith & Nephew, Inc. · Jan 2002
KSEA MONOPOLAR VAPORIZATION ELECTRODES
K001740 · KARL STORZ Endoscopy-America, Inc. · Aug 2000
VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)
K994418 · Ethicon, Inc. · Jan 2000
KSEA HF-SNARE
K983901 · KARL STORZ Endoscopy-America, Inc. · Feb 1999