Panels › General, Plastic Surgery › Product code GEY · Class 1
Motor, Surgical Instrument, Ac-Powered
Regulation 878.4820
0510(k)s in 12 months (41 all time)
0recalls in 12 months (27 all time)
12recalls that name a 510(k)
Top companies in GEY
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 5, 2023 | Pro-Dex Inc KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver Open, Classified |
GEY | None listed |
| Sep 25, 2018 | Pro-Dex Inc PRO-DEX Surgical Driver Battery Pack PDBP-001 Series
PRO-DEX Battery Pack, Single Pouch - PDBP-001-2
PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2
Product Usage:
-The PDBP-001 Battery is a single use Terminated |
GEY | None listed |
| Apr 24, 2017 | Aesculap Implant Systems LLC GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM;
GE426SU; HI-LINE XS DISP.DIAM.BURR X-CRS.I D4.5MM;
GE526R; HI-LINE XS DIAMOND BURR X-CRS.II D4.5MM;
GE526SU; HI-LINE XS DISP.DIAM.BURR X-CRS.II D4 Terminated |
GEY | None listed |
| Apr 24, 2017 | Aesculap Implant Systems LLC GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3;
GP322R; ELAN 4 2-RING DIAMOND BURR COARSE D3.0;
GP323R; ELAN 4 2-RING DIAMOND BURR COARSE D4.0;
GP324R; ELAN 4 2-RING DIAMOND BURR COARSE D5.0;
Terminated |
GEY | None listed |
| Apr 24, 2017 | Aesculap Implant Systems LLC GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0;
GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0;
GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,3;
GP164R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2,3; Terminated |
GEY | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. System Console, Single Port, with irrigation
Product Usage:
Electric system Terminated |
GEY | K080802 |
| Oct 6, 2016 | The Anspach Effort, Inc. Console, eMax2 Plus
Product Usage:
Electric system Terminated |
GEY | K080802 |
| Oct 6, 2016 | The Anspach Effort, Inc. Electronic Foot Control with Direction or Irrigation Switches
Product Usage:
Electric system Terminated |
GEY | K080802 |
| Oct 6, 2016 | The Anspach Effort, Inc. Electronic Foot Control with Direction Switch
Product Usage:
Electric system Terminated |
GEY | K080802 |
| Oct 6, 2016 | The Anspach Effort, Inc. Autolube-III with Irrigation
Product Usage:
Pneumatic system Terminated |
GEY | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. Autolube-III with Foot Guard
Product Usage:
Pneumatic system Terminated |
GEY | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. AL-III-DISS Adapter
Product Usage:
Pneumatic system Terminated |
GEY | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. Autolube-III with 20ft hose
Product Usage:
Pneumatic system Terminated |
GEY | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. Autolube-III
Product Usage:
Pneumatic system Terminated |
GEY | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. Foot control irrigation system
Product Usage:
Pneumatic system Terminated |
GEY | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. AL-III W/ male disconnect and 30ft hose
Product Usage:
Pneumatic system Terminated |
GEY | K011444 |
| Oct 6, 2016 | The Anspach Effort, Inc. AL-III W/ male disconnect and 20ft hose
Product Usage:
Pneumatic system Terminated |
GEY | K011444 |
| Sep 15, 2015 | Nico Corp. NICO Myriad Console
Model number NN-7000
The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primarily consists of a reusable console with foot pedal and Terminated |
GEY | K955168 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***REF-98-0056***Custom Device Autolube III modified with a swivel***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
GEY | K970530 |
| Mar 4, 2014 | MEDICAMAT S.A. Punch Hair Matic
A surgical hair transplant device designed for automation of follicular transplantation. Terminated |
GEY | None listed |
| Feb 24, 2014 | Nico Corp. Myriad handpiece
Tissue morcellator Terminated |
GEY | K955168 |
| Jan 6, 2014 | The Anspach Effort, Inc. Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control).
Cutting and shaping bone. Terminated |
GEY | None listed |
| Mar 6, 2013 | Linvatec Corp. dba ConMed Linvatec D3000I Advantage Drive System, 230v, surgical instrument motor.
Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perfor Terminated |
GEY | K050519 |
| Mar 6, 2013 | Linvatec Corp. dba ConMed Linvatec D3000 Advantage Drive System, 115v
Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and Terminated |
GEY | K050519 |
| Jul 17, 2010 | Linvatec Corp. dba ConMed Linvatec ADVANTAGE Turbo 2-Button Shaver. Rx Only, Made In USA, NON STERILE.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Terminated |
GEY | None listed |
| Sep 21, 2008 | Synthes U S A Power Drive. Battery-driven power tool system intended for use during surgical procedures to provide power to operate various accessories and attachments. Terminated |
GEY | None listed |
| Aug 29, 2006 | Linvatec Corp. ConMed Linvatec MicroChoice Footswitch and ConMed linvatec 3 Pedal Footswitch. Used to operate various surgical handpieces. Terminated |
GEY | None listed |
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