510(k) K951118
- Device
- 3M MAXI-DRIVER II ELECTRIC SYSTEM
- Applicant
- 3M COMPANY
- 510(k) number
- K951118
- Product code
- GEY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-07-06
- Date received
- 1995-03-10
- Regulation
- 878.4820
- Classification name
- Motor, Surgical Instrument, Ac-powered
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLARD LARSON
- Address
- 4320 Vanowen St. Burbank CA US 91505 91505
FDA Registration Numbers#
- 1834331
- 8030965
- 1526534
- 3015610860
- 3003244954
- 2245304
- 8043750
- 3018094310
- 3002807315
- 3000264417
- 3012447612
- 8010379
- 3011276344
- 1828464
- 3003120897
- 3022320321
- 3022589746
- 3009381954
- 3007047889
- 3006438441
- 3010849408
- 8010177
- 1822565
- 3014579188
- 3010813845
- 3023155873
- 3034246209
- 3008110533
- 3006801265
- 1054811
- 3006985163
- 3007366790
- 3005900820
- 3016050940
- 1526439
- 1017294
- 3021907852
- 3009417901
- 3017056829
- 3007997036
- 9617840
- 9610612
- 1643264
- 2032098
- 9615659
- 1818910
- 3015504568
- 1423507
- 3016172274
- 3038503932
- 3009730286
- 3036756245
- 1000655211
- 3027728872
- 2032809
- 3008812251
- 1000655158
- 3011300255
- 3010287737
- 3006561161
- 2648666
- 3008812560
- 3005180920
- 3009217531
- 3015724777
- 1058584
- 3002807310
- 2081135
- 3010097171
- 3005064037
- 2085947
- 3007305485
- 3010707607
- 3014586728
- 3007024186
- 3025603301
- 3008102042
- 3018940271
- 1422375
- 3033509898
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GEY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K050519 | ADVANCED TURBO DRIVE SYSTEM | Linvatec Corp. | 2005-05-17 |
| K020621 | ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS | Arthrocare Corp. | 2002-03-28 |
| K012738 | SYMPHONY GRAFT DELIVERY SYSTEM (GDS) | Depuyacromed | 2001-11-14 |
| K972308 | MEDNEXT 1000 DRILL | Mednext, Inc. | 1997-08-20 |
| K971941 | AQUA SPRAY | Boyd Industries, Inc. | 1997-08-14 |
| K971782 | BONE AND MARROW COLLECTION SYSTEM KIT | Biomedical Ent., Inc. | 1997-07-29 |
| K971268 | BONE & MARROW CLLECTION SYSTEM | Biomedical International Corp. | 1997-07-03 |
| K964252 | ORTHOCHUCK | Buckman Co., Inc. | 1997-05-27 |
| K970530 | ANSPACH LUBRICATING SYSTEM II | The Anspach Effort, Inc. | 1997-05-05 |
| K964073 | BME BONE DRILL BITS | Biomedical Ent., Inc. | 1996-11-14 |
| K962789 | SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM | Smith & Nephew Endoscopy, Inc. | 1996-08-14 |
| K961901 | BONE & MARROW COLLECTION SYSTEM | Biomedical Ent., Inc. | 1996-08-06 |
| K954470 | SURGIMOTOR | W.O.M. World of Medicine GmbH | 1995-12-08 |
| K951773 | PODOSPRAY DRILL SYSTEM | Darco Intl., Inc. | 1995-10-26 |
| K952008 | KARL STORZ DRILL | KARL STORZ Endoscopy-America, Inc. | 1995-07-26 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases