510(k) K031173
- Device
- NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013
- Applicant
- NEEDLETECH PRODUCTS, INC.
- 510(k) number
- K031173
- Product code
- GDF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-07-23
- Date received
- 2003-04-14
- Regulation
- 878.4800
- Classification name
- Guide, Needle, Surgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICK TRIPP
- Address
- 81 W. St. Attleboro MA US 02703 02703
FDA Registration Numbers#
- 9710058
- 3010667733
- 1423507
- 3007597038
- 3003828812
- 3016950436
- 3009077524
- 3008797959
- 9616250
- 3010297540
- 3007766601
- 1928237
- 2132732
- 1123137
- 1320468
- 3011371465
- 1043534
- 1037885
- 1220477
- 1625425
- 3008114965
- 1721504
- 3004983210
- 3005440795
- 3007589150
- 3008936260
- 2030624
- 1820334
- 3042261316
- 3010673850
- 9611112
- 1048735
- 3015831087
- 2529846
- 1423537
- 1211566
- 3004024955
- 3002834291
- 3013503862
- 9613083
- 3021023752
- 1043214
- 1923569
- 1222928
- 3003032798
- 3005809810
- 3033813891
- 3043654467
- 3004749705
- 3006410968
- 3003915875
- 9610612
- 3018094310
- 8010099
- 3009337401
- 3007791595
- 8010298
- 3006897899
- 3040278125
- 8030607
- 3043012074
- 3007024186
- 3001620590
- 3010291427
- 1835568
- 3008808049
- 3038195984
- 1000112137
- 1032347
- 3006942524
- 9681572
- 3011137372
- 3010611926
- 3009649499
- 3006561161
- 1055236
- 3003687489
- 3007200016
- 3014570707
Source Documents#
Other 510(k) Records For Product Code GDF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K950311 | GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE | Global Medical Products, Ltd. | 1995-05-26 |
| K950007 | SURGICAL INSTRUMENT GUIDE | United States Surgical, A Division of Tyco Healthc | 1995-03-15 |
| K945124 | BREAST LESION LOCALIZATION NEEDLE | Promex, Inc. | 1994-11-22 |
| K944942 | BREAST LESION LOCALIZATION NEEDLE | Promedical , Ltd. | 1994-11-04 |
| K935538 | BAUER TEMNO COAXIAL NEEDLE | Bauer Medical, Inc. | 1994-02-22 |
| K935457 | LOCALIZATION WIRE OR MARKER - SURGICAL | Bip USA, Inc. | 1994-02-17 |
| K923840 | NEEDLE-GRABBER | Guardian Angel Products, Inc. | 1993-07-13 |
| K923835 | THE ELEVENTH FINGER | Guardian Angel Products, Inc. | 1993-07-09 |
| K925875 | HORIZONTAL NEEDLE GUIDE ATTACHMENT | Bip USA, Inc. | 1993-04-06 |
| K924270 | BREAST LESION LOCALIZATION NEEDLE | Core Medical, Inc. | 1992-09-23 |
| K923120 | MICROGUIDE LESION MARKING SYSTEM | Angiodynamics, Div. E-Z-Em, Inc. | 1992-09-01 |
| K914941 | SIMON BREAST LESION LOCALIZATION NEEDLE | Manan Medical Products, Inc. | 1992-05-14 |
| K920816 | PERCUGUIDE LESION MARKING | E-Z-Em, Inc. | 1992-04-21 |
| K904172 | ACCUPLACE (TM) | Dlp, Inc. | 1990-11-21 |
| K900903 | KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE | Milex Products, Inc. | 1990-05-03 |
Legacy Summary#
summary
FDA Review#
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