BREAST LOCALIZATION NEEDLES
FDA 510(k) clearance K881730 · decided 1988-05-13
Clearance details
- K-number
- K881730
- Device name
- BREAST LOCALIZATION NEEDLES
- Applicant
- Hart Enterprises, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-04-22
- Decision date
- 1988-05-13
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- GDM
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Wyoming, 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 |
|---|---|---|
| MARROWMINER (K071732) | Stemcor Systems, Inc. | 2007-09-24 |
| BIOACCESS MARROW HARVEST SYSTEM (K971114) | Bioaccess, Inc. | 1997-06-03 |
| ILIAC CREST BONE MARROW ASPIRATION NEEDLE (K953082) | Baxter Healthcare Corp | 1995-09-22 |
| BIOACCESS MARROW HARVEST SYSTEM (K953064) | Bioaccess, Inc. | 1995-08-07 |
| ENDO-NEEDLE INSTRUMENT (K936207) | Gerard Medical, Inc. | 1994-06-16 |
| ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE (K930160) | Symbiosis Corp. | 1993-07-06 |
| BONE MARROW BIOPSY SYSTEM (K923872) | The Straumann Co. | 1992-12-15 |
| BECTON DICKINSON MODIFIED MENGHINI NEEDLE (K915572) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-02-03 |
| NA NEEDLES (K904667) | Olympus Corp. | 1990-12-12 |
| ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U (K903747) | Downs Surgical , Ltd. | 1990-10-31 |
| ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E (K903750) | Downs Surgical , Ltd. | 1990-10-31 |
| ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U (K903749) | Downs Surgical , Ltd. | 1990-10-31 |
Recalls involving this device
No recalls on record reference this clearance.