Cleared Traditional

K993777 - DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES

K993777 is an FDA 510(k) clearance for DISPOSABLE AND REUSABLE BALL AND LOOP E..., manufactured by R-Group Intl.. The device is a Class 2 Obstetrics & Gynecology device with product code HGI cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K993777 · R-Group Intl. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
199d
Days
Class 2
Risk

K993777 is an FDA 510(k) clearance for the DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES. Classified as Electrocautery, Gynecologic (and Accessories) (product code HGI), Class II - Special Controls.

Submitted by R-Group Intl. (Gainesville, US). The FDA issued a Cleared decision on May 25, 2000 after a review of 199 days - an extended review cycle.

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 R-Group Intl. devices

FDA 510(k) Submission Details - K993777

510(k) Number K993777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1999
Decision Date May 25, 2000
Days to Decision 199 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
39d slower than avg
Panel avg: 160d · This submission: 199d
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 32
Devices cleared under the same product code (HGI) and FDA review panel - the closest regulatory comparables to K993777.
DOMAIN SURGICAL SYSTEM
K121881 · Domain Surgical, Inc. · Oct 2012
SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY
K003608 · Aesculap, Inc. · Feb 2001
LOOP ELECTRODE, BALL ELECTRODE
K993527 · Palm Medical USA, Inc. · Jul 2000
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)
K983840 · Wallach Surgical Devices, Inc. · May 1999
GYNEX ELECTRODES
K982739 · Gynex Corp. · Mar 1999
ROCKET ELECTRODE
K974138 · A & A Medical, Inc. · Jan 1998