Cleared Traditional

K003608 - SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY

K003608 is an FDA 510(k) clearance for SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNEC..., manufactured by Aesculap, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K003608 · Aesculap, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
90d
Days
Class 2
Risk

K003608 is an FDA 510(k) clearance for the SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY. Classified as Electrocautery, Gynecologic (and Accessories) (product code HGI), Class II - Special Controls.

Submitted by Aesculap, Inc. (Allentown, US). The FDA issued a Cleared decision on February 20, 2001 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4120 - 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 Aesculap, Inc. devices

FDA 510(k) Submission Details - K003608

510(k) Number K003608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2000
Decision Date February 20, 2001
Days to Decision 90 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 160d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGI Device Classification - Class 2, Special Controls

Product Code HGI Electrocautery, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4120
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 - HGI Electrocautery, Gynecologic (and Accessories)

All 33
Devices cleared under the same product code (HGI) and FDA review panel - the closest regulatory comparables to K003608.
Liger Medical HTU-110
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FMWAND FERROMAGNETIC SURGICAL SYSTEM
K130606 · Domain Surgical, Inc. · Jan 2014
DOMAIN SURGICAL SYSTEM
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LOOP ELECTRODE, BALL ELECTRODE
K993527 · Palm Medical USA, Inc. · Jul 2000
DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES
K993777 · R-Group Intl. · May 2000
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)
K983840 · Wallach Surgical Devices, Inc. · May 1999