SPACER
FDA 510(k) clearance K925870 · decided 1993-05-19
Clearance details
- K-number
- K925870
- Device name
- SPACER
- Applicant
- Bip USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-11-19
- Decision date
- 1993-05-19
- Days to decision
- 181 days
- Clearance type
- Traditional
- Product code
- MJG
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Niagara Falls, NY, 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 |
|---|---|---|
| PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM (K080674) | PAJUNK GmbH Medizintechnologie | 2008-05-09 |
| EXICLIP EXCS-M (K070836) | Clevex, Inc. | 2007-04-20 |
| ECHO-COAT ULTRASOUND NEEDLES (K983647) | Sts Biopolymers | 1999-01-20 |
| RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY (K955683) | Contour Fabricators of Florida, Inc. | 1996-02-01 |
| SKIN BIOPSY DEVICE (K933324) | Nhr, Inc. | 1994-03-31 |
| DYNACYT BIOPSY ASPIRATION DEVICE (K922919) | Buckman Co., Inc. | 1993-03-31 |
Recalls involving this device
No recalls on record reference this clearance.