EVER-SHARP BIOPSY FORCEPS
FDA 510(k) clearance K895303 · decided 1990-01-16
Clearance details
- K-number
- K895303
- Device name
- EVER-SHARP BIOPSY FORCEPS
- Applicant
- Southwest Medical Mfg., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-08-29
- Decision date
- 1990-01-16
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- HFB
- Device class
- 1
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Marietta, GA, 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 |
|---|---|---|
| SPIRABRUSH CX BIOPSY INSTRUMENT (K011488) | Trylon Corp. | 2002-02-22 |
| CIT BIOPSY PUNCHES (K944444) | Chirurgische Instrumente | 1995-09-29 |
| SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS (K930773) | Symbiosis Corp. | 1994-07-28 |
| FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY (K933767) | Mahe-Medizintechnik | 1994-05-26 |
| OWENS BIOPSY FORCEPS (K926595) | Owens Industries, Inc. | 1994-05-25 |
| ROTO FIT BIOPSY FORCEPS (K926527) | Thomasville Medical Assoc. | 1994-02-25 |
| THOMAS MEDICAL BIOPSY FORCEPS (K930036) | Thomasville Medical Assoc. | 1994-02-24 |
| TISCHLER BIOPSY FORCEPS (K926538) | Thomasville Medical Assoc. | 1994-02-24 |
| OWENS BIOPSY FORCEPS (K924224) | Owens Precision Systems, Inc. | 1994-02-04 |
| CROAK OVARIAN BIOPSY FORCEP (K902049) | Gynescope Corp. | 1990-06-07 |
| ROTO FIT BIOPSY FORCEPS (K891043) | Zinnanti Surgical Instruments, Inc. | 1989-03-22 |
| TISCHLER BIOPSY FORCEPS (K891034) | Zinnanti Surgical Instruments, Inc. | 1989-03-17 |
Recalls involving this device
No recalls on record reference this clearance.