510(k) K013040
- Device
- LIGHT SABER INTRODUCER NEEDLE
- Applicant
- Minrad, Inc.
- 510(k) number
- K013040
- Product code
- MDM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-12-07
- Date received
- 2001-09-10
- Regulation
- 878.4800
- Classification name
- Instrument, Manual, Surgical, General Use
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- HOWARD M HOLSTEIN
- Address
- 555 Thirdteenth St., NW Washington DC US 20004 20004
FDA Registration Numbers#
- 3010097171
- 3007279848
- 9610557
- 3001239363
- 3038252369
- 3008496217
- 1424263
- 3027234828
- 3007305589
- 3010521050
- 3015526995
- 3017607477
- 3003644849
- 3006142527
- 2182979
- 3008797959
- 9617592
- 8010769
- 3010131978
- 9616246
- 3008824562
- 3035858921
- 3004111573
- 3004552850
- 1926681
- 1416666
- 3007389672
- 2431166
- 3015490794
- 3004358587
- 8043769
- 3026311512
- 3008593890
- 3016170492
- 3004871905
- 3035708926
- 3016069968
- 3012130008
- 3004450489
- 3004034546
- 2916714
- 1055890
- 3010889707
- 3007319107
- 1833920
- 3007663056
- 1835998
- 2246990
- 3011106828
- 3008254127
- 8010254
- 1649390
- 1043644
- 3012185136
- 3017196117
- 3010041511
- 3029507159
- 3015679904
- 3006498370
- 3006765019
- 3034286426
- 3027339877
- 8043746
- 3009251316
- 3004513970
- 3007329020
- 3003019064
- 3004125670
- 1319639
- 3010864832
- 2246552
- 1222780
- 3003988575
- 3005726885
- 1000517406
- 3014273557
- 3007137643
- 3029082594
- 9680271
Source Documents#
Other 510(k) Records For Product Code MDM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K073664 | FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER | Injectimed, Inc. | 2008-08-08 |
| K050575 | FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM | Futumeds Sdn Bhd | 2005-08-15 |
| K050957 | EUTROCHAR | Special Devices, Inc. | 2005-05-18 |
| K023173 | ANDREWS INTRODUCER, MODEL ASI01 | Andrews Surgical Innovations, Ltd. | 2002-12-18 |
| K022059 | MICROVASIVE PULMONARY GUIDEWIRE | Boston Scientific Corp | 2002-11-13 |
| K010184 | CHESS HAND SURGERY SYSTEM | Canica Design, Inc. | 2001-06-22 |
| K990062 | SAPHLIFT | Genzyme Surgical Product (Genzyme Biosurgery) | 1999-03-30 |
| K981579 | ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG | ETHICON, Inc. | 1998-07-09 |
| K943968 | TUNNELER | Denver Biomedicals, Inc. | 1995-03-01 |
| K945430 | DERMAVBLADE(TM) | Hasting'S Biomedical Corp. | 1994-11-28 |
| K941193 | EAST WEST INSTRUMENTS | East West Instruments, Inc. | 1994-11-09 |
| K941907 | APEX DISPOSABLE INSTRUMENTS | Apex Ent., Inc. | 1994-08-26 |
| K942818 | DEEP SUTURE | Automated Medical Products Corp. | 1994-08-25 |
| K942896 | CLAMPS AND CLIPS | Surgin Surgical Instrumentation, Inc. | 1994-07-19 |
| K940684 | SURGICAL INSTRUMENT, DISPOSABLE | Her-Mar, Inc. | 1994-03-14 |