Cleared Special

K180063 - OCM-G1 Attachment

K180063 is the FDA 510(k) clearance for OCM-G1 Attachment by The Anspach Effort, Inc.. It is a Class 2 Ear, Nose, Throat device (product code ERL) cleared through the Special 510(k) pathway after a 77-day FDA review.

K180063 · The Anspach Effort, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
77d
Days
Class 2
Risk

K180063 is an FDA 510(k) clearance for the OCM-G1 Attachment. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on March 27, 2018 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4250 - the FDA ear, nose and throat device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all The Anspach Effort, Inc. devices

Submission Details

510(k) Number K180063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2018
Decision Date March 27, 2018
Days to Decision 77 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 89d · This submission: 77d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4250
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

All 54
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K180063.
Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000
K211490 · Stryker Corporation · Jun 2021
UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece
K200318 · KARL STORZ Endoscopy-America, Inc. · Oct 2020
EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand
K190715 · Interscope, Inc. · Dec 2019
Stryker Consolidated Operating Room Equipment (CORE) 2 Console
K171840 · Stryker Corporation · Sep 2017
DIEGO ELITE DRILL
K152744 · Gyrus Acmi, Inc. · Jun 2016
Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces
K150969 · KARL STORZ Endoscopy-America, Inc. · Jan 2016