Cleared Traditional

K061651 - FISCHER CONE BIOPSY EXCISOR

K061651 is an FDA 510(k) clearance for FISCHER CONE BIOPSY EXCISOR, manufactured by Apple Medical Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HGI cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K061651 · Apple Medical Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
129d
Days
Class 2
Risk

K061651 is an FDA 510(k) clearance for the FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158. Classified as Electrocautery, Gynecologic (and Accessories) (product code HGI), Class II - Special Controls.

Submitted by Apple Medical Corp. (Marlboro, US). The FDA issued a Cleared decision on October 20, 2006 after a review of 129 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.

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FDA 510(k) Submission Details - K061651

510(k) Number K061651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2006
Decision Date October 20, 2006
Days to Decision 129 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 160d · This submission: 129d
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 K061651.
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SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY
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K983840 · Wallach Surgical Devices, Inc. · May 1999
VALLEY FORGE BIPOLAR LOOP
K971986 · Valley Forge Scientific Corp. · Aug 1997
TBD
K965245 · Utah Medical Products, Inc. · Jul 1997
WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM
K963653 · Wallach Surgical Devices, Inc. · Jun 1997