ACCUPLACE (TM)
FDA 510(k) clearance K904172 · decided 1990-11-21
Clearance details
- K-number
- K904172
- Device name
- ACCUPLACE (TM)
- Applicant
- Dlp, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-09-11
- Decision date
- 1990-11-21
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- GDF
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Grand Rapids, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013 (K031173) | Needle Tech Products, Inc. | 2003-07-23 |
| GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE (K950311) | Global Medical Products, Ltd. | 1995-05-26 |
| SURGICAL INSTRUMENT GUIDE (K950007) | United States Surgical, A Division of Tyco Healthc | 1995-03-15 |
| BREAST LESION LOCALIZATION NEEDLE (K945124) | Promex, Inc. | 1994-11-22 |
| BREAST LESION LOCALIZATION NEEDLE (K944942) | Promedical , Ltd. | 1994-11-04 |
| BAUER TEMNO COAXIAL NEEDLE (K935538) | Bauer Medical, Inc. | 1994-02-22 |
| LOCALIZATION WIRE OR MARKER - SURGICAL (K935457) | Bip USA, Inc. | 1994-02-17 |
| NEEDLE-GRABBER (K923840) | Guardian Angel Products, Inc. | 1993-07-13 |
| THE ELEVENTH FINGER (K923835) | Guardian Angel Products, Inc. | 1993-07-09 |
| HORIZONTAL NEEDLE GUIDE ATTACHMENT (K925875) | Bip USA, Inc. | 1993-04-06 |
| BREAST LESION LOCALIZATION NEEDLE (K924270) | Core Medical, Inc. | 1992-09-23 |
| MICROGUIDE LESION MARKING SYSTEM (K923120) | Angiodynamics, Div. E-Z-Em, Inc. | 1992-09-01 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| (Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle recall (Z-1037-2016) | Stryker Instruments Div. of Stryker Corporation | 2016-03-03 |
| (Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at recall (Z-1038-2016) | Stryker Instruments Div. of Stryker Corporation | 2016-03-03 |
| 50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a recall (Z-1039-2016) | Stryker Instruments Div. of Stryker Corporation | 2016-03-03 |
| 50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a recall (Z-1040-2016) | Stryker Instruments Div. of Stryker Corporation | 2016-03-03 |