SOFT TISSUE BIOPSY DEVICE
FDA 510(k) clearance K882013 · decided 1988-06-15
Clearance details
- K-number
- K882013
- Device name
- SOFT TISSUE BIOPSY DEVICE
- Applicant
- Ocean Medical Products, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1988-05-13
- Decision date
- 1988-06-15
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- DWO
- 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 |
|---|---|---|
| PROMED BIOPSY NEEDLE (K933364) | Vlv Associates, Inc. | 1994-02-15 |
| ULTRA-CORE BIOPSY NEEDLES (K921418) | Medical Device Technologies, Inc. | 1992-06-19 |
| AUTOMATED BIOPSY DEVICE, MODIFICATION (K913815) | Hart Enterprises, Inc. | 1991-10-30 |
| MANAN BONE MARROW BIOPSY NEEDLE (K890925) | Manan Medical Products, Inc. | 1989-04-11 |
| MEDSURG GREENE NEEDLE (K885145) | Medsurg Industries, Inc. | 1989-03-14 |
| NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE (K885149) | Hart Enterprises, Inc. | 1989-01-26 |
| ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE (K874585) | Angiomed U.S., Inc. | 1987-12-02 |
| FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE (K872597) | Dianon Systems, Inc. | 1987-07-28 |
| ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES (K853312) | Argon Medical Corp. | 1985-09-12 |
| RNG SERIES ULTRASOUND NEEDLE/CATH. GDS (K820269) | CIVCO Medical Instruments Co., Inc. | 1982-03-23 |
Recalls involving this device
No recalls on record reference this clearance.