Motor, Surgical Instrument, Ac-Powered
FDA product code GEY · Class I (low risk) · 21 CFR 878.4820 · General, Plastic Surgery
41510(k) clearances
0PMA approvals
26recalls
Manufacturers
- Biomedical Ent., Inc. 3
- American Surgical Laser, Inc. 3
- The Anspach Effort, Inc. 3
- Micro Surgical Instruments Corp. 3
- Micro-Aire Surgical Instruments, Inc. 2
- Orthopedic Systems, Inc. 2
- Mcghan Medical Corp. 2
- Black & Decker(Tm) 2
- Linvatec Corp. 2
- Vistek Corp. 1
- Arthrocare Corp. 1
- Darco Intl., Inc. 1
- KARL STORZ Endoscopy-America, Inc. 1
- 3M Company 1
- Acro-Poly, Inc. 1
- Elekta Instruments, Inc. 1
- Aesculap, Inc. 1
- Surgical Innovators of America, Inc. 1
- Storz Instrument Co. 1
- Richards Medical Co., Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050519 | Advanced Turbo Drive SystemGEY · Special | Linvatec Corp. | 05/17/2005SE |
| K020621 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; WandsGEY · Special | Arthrocare Corp. | 03/28/2002SE |
| K012738 | Symphony Graft Delivery System (GDS)GEY · Traditional | Depuyacromed | 11/14/2001SE |
| K972308 | Mednext 1000 DrillGEY · Traditional | Mednext, Inc. | 08/20/1997SE |
| K971941 | Aqua SprayGEY · Traditional | Boyd Industries, Inc. | 08/14/1997SE |
| K971782 | Bone and Marrow Collection System KitGEY · Traditional | Biomedical Ent., Inc. | 07/29/1997SE |
| K971268 | Bone & Marrow Cllection SystemGEY · Traditional | Biomedical International Corp. | 07/03/1997SE |
| K964252 | OrthochuckGEY · Traditional | Buckman Co., Inc. | 05/27/1997SE |
| K970530 | Anspach Lubricating System IIGEY · Traditional | The Anspach Effort, Inc. | 05/05/1997SE |
| K964073 | Bme Bone Drill BitsGEY · Traditional | Biomedical Ent., Inc. | 11/14/1996SE |
| K962789 | Surgical Kit-Acufex Mosaicplasty SystemGEY · Traditional | Smith & Nephew Endoscopy, Inc. | 08/14/1996SE |
| K961901 | Bone & Marrow Collection SystemGEY · Traditional | Biomedical Ent., Inc. | 08/06/1996SE |
| K954470 | SurgimotorGEY · Traditional | W.O.M. World of Medicine GmbH | 12/08/1995SE |
| K951773 | Podospray Drill SystemGEY · Traditional | Darco Intl., Inc. | 10/26/1995SE |
| K952008 | Karl Storz DrillGEY · Traditional | KARL STORZ Endoscopy-America, Inc. | 07/26/1995SE |
| K951118 | 3M Maxi-Driver II Electric SystemGEY · Traditional | 3M Company | 07/06/1995SE |
| K940535 | Auto Lube SystemGEY · Traditional | The Anspach Effort, Inc. | 03/21/1994SE |
| K934172 | Acro-Poly, Inc. Handpiece/Anglehead Accessories for Surgical InstumentsGEY · Traditional | Acro-Poly, Inc. | 10/27/1993SE |
| K932700 | Cuto(Tm) Tissue Morcellation SystemGEY · Traditional | Linvatec Corp. | 10/15/1993SE |
| K925360 | ES-100 Power System, ES-100 SeriesGEY · Traditional | Elekta Instruments, Inc. | 09/07/1993SE |
| K913262 | Aesculap Surgical AccessoriesGEY · Traditional | Aesculap, Inc. | 12/30/1991SE |
| K913369 | Micro-Aire Model 2060GEY · Traditional | Micro Surgical Instruments Corp. | 11/01/1991SE |
| K913266 | Micro-Aire Model 2050E/ELEC Handpiece/TrottlelessGEY · Traditional | Micro Surgical Instruments Corp. | 10/21/1991SE |
| K905383 | 2710-000 Oscillating Saw, General AssemblyGEY · Traditional | Micro Surgical Instruments Corp. | 06/18/1991SE |
| K904682 | Vistek Electronic ControllerGEY · Traditional | Vistek Corp. | 12/18/1990SE |
| K900033 | Micro-Aire Powered Micro-Surgery InstrumentsGEY · Traditional | Micro-Aire Surgical Instruments, Inc. | 02/13/1990SE |
| K882654 | Physiotron(Tm) Microsurgical Motor & Cooling Sys.GEY · Traditional | Surgical Innovators of America, Inc. | 09/20/1988SE |
| K873476 | Mini-Motor Hand Engine & Access. Dermabrasion BursGEY · Traditional | Mcghan Medical Corp. | 09/11/1987SE |
| K873475 | Micro-Torque Hand Engine & Access. Dermabra. BursGEY · Traditional | Mcghan Medical Corp. | 09/11/1987SE |
| K853778 | The Dextra Precision Power UnitGEY · Traditional | Storz Instrument Co. | 11/13/1985SE |
| K853762 | Isometric Acl Drill GuideGEY · Traditional | Orthopedic Systems, Inc. | 10/07/1985SE |
| K853761 | Drilling TemplateGEY · Traditional | Orthopedic Systems, Inc. | 10/07/1985SE |
| K850389 | Multiple Outlet ManifoldGEY · Traditional | The Anspach Effort, Inc. | 03/18/1985SE |
| K843519 | Minuteman CO2 Microsurg Laser Gen SurgGEY · Traditional | American Surgical Laser, Inc. | 12/07/1984SE |
| K843518 | Minuteman C02 Microsurg Laser PodiatryGEY · Traditional | American Surgical Laser, Inc. | 12/07/1984SE |
| K843517 | Minuteman CO2 Microsurg Laser Dermatol-GEY · Traditional | American Surgical Laser, Inc. | 12/07/1984SE |
| K842475 | Richards Intra-Articular Shaver MotorGEY · Traditional | Richards Medical Co., Inc. | 09/17/1984SE |
| K841165 | Electro Surgery SystemGEY · Traditional | Micro-Aire Surgical Instruments, Inc. | 06/05/1984SE |
| K830153 | Richards Intra-Articular Shaver BladesGEY · Traditional | Richard'S Medical Equip., Inc. | 02/28/1983SE |
| K812438 | Sagittal SawGEY · Traditional | Black & Decker(Tm) | 11/02/1981SE |
| K812437 | 150 Driver ReamerGEY · Traditional | Black & Decker(Tm) | 11/02/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2098-2023 Class II | KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in…Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle… | Pro-Dex Inc | 02/15/2023Open, Classified |
| Z-2340-2019 Class II | PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch…Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical… | Pro-Dex Inc | 09/25/2018Terminated |
| Z-2089-2017 Class II | GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS DISP.DIAM.BURR…Diamond particulates may break off the burr and fall into the surgical site. If the particles are not… | Aesculap Implant Systems LLC | 03/28/2017Terminated |
| Z-2088-2017 Class II | GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-RING DIAMOND BURR…Diamond particulates may break off the burr and fall into the surgical site. If the particles are not… | Aesculap Implant Systems LLC | 03/28/2017Terminated |
| Z-2087-2017 Class II | GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAMOND BURR+…Diamond particulates may break off the burr and fall into the surgical site. If the particles are not… | Aesculap Implant Systems LLC | 03/28/2017Terminated |
| Z-1956-2017 Class II | System Console, Single Port, with irrigation Product Usage: Electric systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1955-2017 Class II | Console, eMax2 Plus Product Usage: Electric systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1949-2017 Class II | Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric…Supplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1948-2017 Class II | Electronic Foot Control with Direction Switch Product Usage: Electric systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1938-2017 Class II | Autolube-III with Irrigation Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1937-2017 Class II | Autolube-III with Foot Guard Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1936-2017 Class II | AL-III-DISS Adapter Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1935-2017 Class II | Autolube-III with 20ft hose Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1934-2017 Class II | Autolube-III Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1933-2017 Class II | Foot control irrigation system Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1932-2017 Class II | AL-III W/ male disconnect and 30ft hose Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1931-2017 Class II | AL-III W/ male disconnect and 20ft hose Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-2767-2015 Class II | NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system…Two cables within the console were inadvertently twisted during manufacturing. The individual wires within… | Nico Corp. | 07/29/2015Terminated |
| Z-2045-2016 Class II | Myriad handpiece Tissue morcellatorThis recall has been initiated due to a defective component within the handpiece which will cause the… | Nico Corp. | 02/24/2014Terminated |
| Z-1129-2014 Class II | Punch Hair Matic A surgical hair transplant device designed for automation of follicular…Medicamat is initiating a field correction due to misbranded marketing literature for the Punch Hair Matic… | Medicamat S.A. | 02/18/2013Terminated |
| Z-0917-2013 Class III | D3000I Advantage Drive System, 230v, surgical instrument motor. Product Usage: The…The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207, used on… | Linvatec Corp. dba ConMed Linvatec | 01/24/2013Terminated |
| Z-0916-2013 Class III | D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function…The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207, used on… | Linvatec Corp. dba ConMed Linvatec | 01/24/2013Terminated |
| Z-1903-2014 Class II | ANSPACH***REF-98-0056***Custom Device Autolube III modified with a swivel***Rx Only***…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | The Anspach Effort, Inc. | 11/28/2012Terminated |
| Z-0631-2014 Class II | Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and…Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where… | The Anspach Effort, Inc. | 06/11/2012Terminated |
| Z-2026-2010 | ADVANTAGE Turbo 2-Button Shaver. Rx Only, Made In USA, NON STERILE. CONMED LINVATEC…ConMed Linvatec is recalling Advantage, 2-Button Turbo Handpiece Catalog Number D9924. These products may… | Linvatec Corp. dba ConMed Linvatec | 10/29/2009Terminated |
| Z-2395-2008 | Power Drive. Battery-driven power tool system intended for use during surgical…The product is mislabeled, as the validation for the previous sterilization parameters cannot be replicated.… | Synthes U S A | 07/23/2008Terminated |