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) Official FDA 510(k) Summary (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.

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
71d faster than avg
Panel avg: 161d · 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 52
Devices cleared under the same product code (HGI) and FDA review panel - the closest regulatory comparables to K003608.
ENDOCERVICAL ELECTRODE # 2
K070877 · Modern Medical Equipment Mfg., Ltd. · Jul 2007
FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158
K061651 · Apple Medical Corp. · Oct 2006
THOMAS MEDICAL ELECTRODES
K022593 · Thomas Medical, Inc. · Nov 2002
TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018
K002042 · New England Medical Corp. · Feb 2001
LOOP ELECTRODE, BALL ELECTRODE
K993527 · Palm Medical USA, Inc. · Jul 2000
DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES
K993777 · R-Group Intl. · May 2000
K003608 · SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY
Download PDF FDA Summary Aesculap, Inc.