510(k) K930773
- Device
- SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS
- Applicant
- SYMBIOSIS CORP.
- 510(k) number
- K930773
- Product code
- HFB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-07-28
- Date received
- 1993-02-16
- Regulation
- 884.4530
- Classification name
- Forceps, Biopsy, Gynecological
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KEVIN W SMITH
- Address
- 8600 NW 41 St. Miami FL US 33166 33166
FDA Registration Numbers#
- 3008280196
- 3014334038
- 2529846
- 9680424
- 1923569
- 3008902714
- 3017911818
- 3003644849
- 3004608878
- 2183650
- 8010769
- 9616246
- 3031564283
- 9616250
- 3004111573
- 3005440795
- 3004552850
- 8044057
- 1416666
- 2431166
- 2434839
- 3032747418
- 3010687973
- 8043769
- 3006591312
- 8043752
- 9616088
- 3035708926
- 3004001706
- 3005067367
- 3003431869
- 3011137372
- 8010257
- 1420054
- 8010370
- 2916714
- 3001620590
- 3002834291
- 8040884
- 1055890
- 3012267976
- 9611616
- 9680519
- 3008812251
- 3008711893
- 3005695838
- 3023657851
- 9611112
- 3013011598
- 9680518
- 3010041511
- 2032098
- 3009513193
- 3029929134
- 3006487092
- 3030839824
- 8040233
- 8010877
- 3003882387
- 3007137643
- 3029082594
- 3006389770
- 9681540
- 1720747
- 8010251
- 9611283
- 3001084743
- 3013358456
- 3015972835
- 3008338766
- 9710524
- 1216677
- 1928237
- 3002675176
- 8010168
- 2511556
- 1412854
- 3010155661
- 8010372
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HFB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K011488 | SPIRABRUSH CX BIOPSY INSTRUMENT | Trylon Corp. | 2002-02-22 |
| K944444 | CIT BIOPSY PUNCHES | Chirurgische Instrumente | 1995-09-29 |
| K933767 | FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY | Mahe-Medizintechnik | 1994-05-26 |
| K926595 | OWENS BIOPSY FORCEPS | Owens Industries, Inc. | 1994-05-25 |
| K926527 | ROTO FIT BIOPSY FORCEPS | Thomasville Medical Assoc. | 1994-02-25 |
| K926538 | TISCHLER BIOPSY FORCEPS | Thomasville Medical Assoc. | 1994-02-24 |
| K930036 | THOMAS MEDICAL BIOPSY FORCEPS | Thomasville Medical Assoc. | 1994-02-24 |
| K924224 | OWENS BIOPSY FORCEPS | Owens Precision Systems, Inc. | 1994-02-04 |
| K902049 | CROAK OVARIAN BIOPSY FORCEP | Gynescope Corp. | 1990-06-07 |
| K895303 | EVER-SHARP BIOPSY FORCEPS | Southwest Medical Mfg., Inc. | 1990-01-16 |
| K891043 | ROTO FIT BIOPSY FORCEPS | Zinnanti Surgical Instruments, Inc. | 1989-03-22 |
| K891027 | ZSI BIOPSY FORCEPS | Zinnanti Surgical Instruments, Inc. | 1989-03-17 |
| K891034 | TISCHLER BIOPSY FORCEPS | Zinnanti Surgical Instruments, Inc. | 1989-03-17 |
| K890380 | CERVICAL BIOPSY FORCEPS | Kinetic Medical Products | 1989-02-27 |
| K852357 | GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP | Gyneco, Inc. | 1985-07-05 |
Legacy Summary#
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FDA Review#
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