Panels › Ear, Nose, Throat › Product code ERL · Class 2
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Regulation 874.4250
0510(k)s in 12 months (91 all time)
0recalls in 12 months (29 all time)
26recalls that name a 510(k)
Top companies in ERL
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 15, 2021 | Medtronic Xomed, Inc. Software 1898072 IPC upgrade v 2.7.3.0, IPC System:
a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC Terminated |
ERL | K081277 K081475 |
| Sep 11, 2020 | Bien-Air Surgery Sa Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues a Open, Classified |
ERL | K083720 |
| Sep 11, 2020 | Bien-Air Surgery Sa Stryker Instruments REF 5452-007-000 SN *******
S2 MINI FOOT Pedal - Product Usage:
The S2 Mini Drill System has been designed for the light drilling of bones as part of surgical operations such as Open, Classified |
ERL | K143492 |
| Sep 11, 2020 | Bien-Air Surgery Sa Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat Open, Classified |
ERL | K143492 |
| Sep 11, 2020 | Bien-Air Surgery Sa Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical energy to mechanically drive attachment, microsaws, shaver blade Open, Classified |
ERL | K083720 |
| Sep 11, 2020 | Bien-Air Surgery Sa Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones. Open, Classified |
ERL | K792159 |
| Jun 12, 2020 | Medtronic Xomed, Inc. Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures. Terminated |
ERL | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. Foot Control without Switches, SC2100
Product Usage:
Electric system Terminated |
ERL | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. Foot Control, SC2100
Product Usage:
Electric system Terminated |
ERL | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. Electronic Foot Control with Direction or Irrigation Switches
Product Usage:
Electric system Terminated |
ERL | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. XMAX Motor, High Strength Hose
Product Usage:
Pneumatic system Terminated |
ERL | K965080 |
| Oct 6, 2016 | The Anspach Effort, Inc. XMAX Motor (Pneumatic Drill System)
Product Usage:
Pneumatic system Terminated |
ERL | K965080 |
| Mar 28, 2016 | The Anspach Effort, Inc. ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD
Product Usage:
The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bon Terminated |
ERL | K131053 |
| Mar 28, 2016 | The Anspach Effort, Inc. ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD
Product Usage:
The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping Terminated |
ERL | K131053 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
ERL | K965080 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***Custom XMax Motor, Pneumatic***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
ERL | K965080 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***REF 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Custom Autolube III IRR Foot Pedal***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
ERL | K965080 |
| Apr 30, 2014 | Laurimed LLC PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which acces Terminated |
ERL | K133133 |
| Mar 20, 2014 | Stryker Instruments Div. of Stryker Corporation 2.5MM Aggressive Blade
Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub.
ENT Precision C Terminated |
ERL | K011381 |
| Jan 16, 2014 | The Anspach Effort, Inc. Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only
MIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, including the spine and cranium. Terminated |
ERL | K011444 K965080 |
| Jan 9, 2014 | The Anspach Effort, Inc. ***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc.
Intended for cutting and shaping bone. Terminated |
ERL | K965080 |
| Jan 9, 2014 | The Anspach Effort, Inc. ***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc.
Intended for cutting and shaping bone. Terminated |
ERL | K965080 |
| Jul 16, 2013 | Stryker Instruments Div. of Stryker Corporation RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only
The RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment ( Terminated |
ERL | K040300 |
| Jul 16, 2013 | Stryker Instruments Div. of Stryker Corporation CORE Universal Driver REF 5400- 99 Rx Only
This drill may also be used with theTotal Performance System (TPS").The Stryker Total Performance System (TPS) is intended for usein the cutting, drilling, Terminated |
ERL | K040300 |
| Jul 16, 2013 | Stryker Instruments Div. of Stryker Corporation Stryker TPS Universal Driver REF 5100- 99 Rx ,
The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone rel Terminated |
ERL | K040300 |
| Nov 13, 2009 | Medtronic Xomed, Inc. Medtronic Integrated Power Console System, IP X1
REF 1898001 or REF EC300
Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA.
Distributed by: Medtronic Powered Surg Terminated |
ERL | K002828 |
| Feb 13, 2008 | The Anspach Effort, Inc. Anspach Xmax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410. Terminated |
ERL | None listed |
| Feb 13, 2008 | The Anspach Effort, Inc. Anspach MicroMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410. Terminated |
ERL | None listed |
| Feb 13, 2008 | The Anspach Effort, Inc. Anspach BlackMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410. Terminated |
ERL | K831756 K965080 |
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