Cleared Traditional

K965245 - TBD

K965245 is an FDA 510(k) clearance for TBD, manufactured by Utah Medical Products, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGI cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K965245 · Utah Medical Products, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
184d
Days
Class 2
Risk

K965245 is an FDA 510(k) clearance for the TBD. Classified as Electrocautery, Gynecologic (and Accessories) (product code HGI), Class II - Special Controls.

Submitted by Utah Medical Products, Inc. (Midvale, US). The FDA issued a Cleared decision on July 3, 1997 after a review of 184 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 Utah Medical Products, Inc. devices

FDA 510(k) Submission Details - K965245

510(k) Number K965245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1996
Decision Date July 03, 1997
Days to Decision 184 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
24d slower than avg
Panel avg: 160d · This submission: 184d
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 25
Devices cleared under the same product code (HGI) and FDA review panel - the closest regulatory comparables to K965245.
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)
K983840 · Wallach Surgical Devices, Inc. · May 1999
ROCKET ELECTRODE
K974138 · A & A Medical, Inc. · Jan 1998
VALLEY FORGE BIPOLAR LOOP
K971986 · Valley Forge Scientific Corp. · Aug 1997
WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM
K963653 · Wallach Surgical Devices, Inc. · Jun 1997
WALLACH INTEGRATION UNIT
K963348 · Wallach Surgical Devices, Inc. · Mar 1997
KSEA THERMOCOAGULATOR (MODEL 265100 20)
K963852 · KARL STORZ Endoscopy-America, Inc. · Dec 1996