Product code HFB
- Device name
- Forceps, Biopsy, Gynecological
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 1
- Regulation number
- 884.4530
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| K930773 | SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS | Symbiosis Corp. | 1994-07-28 |
| 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 |
| K930036 | THOMAS MEDICAL BIOPSY FORCEPS | Thomasville Medical Assoc. | 1994-02-24 |
| K926538 | TISCHLER 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 |
| K891034 | TISCHLER BIOPSY FORCEPS | Zinnanti Surgical Instruments, Inc. | 1989-03-17 |
| K891027 | ZSI 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 |
| K851110 | GAYLOR-THOMS UTERINE BIOPSY FORCEPS 1810-144 PCS. | The Huxley Instrument Corp. | 1985-04-08 |
| K842112 | TISCHLER CERVICAL BIOPSY PUNCH FORCEPS | J. Sklar Mfg. Co., Inc. | 1984-07-03 |
| K840352 | CIN-SHEAR | Roland J. Zwick, Inc. | 1984-04-05 |
| K820519 | BIOPSER | Advanced Biomedical Instruments | 1982-04-29 |
| K802458 | KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611 | J. Sklar Mfg. Co., Inc. | 1981-01-12 |
| K802457 | KEVORKIAN-YOUNGE BIOPSY PUNCH, #90-6610 | J. Sklar Mfg. Co., Inc. | 1981-01-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G422BP0190 | "BABY TISCHLER BIOPSY PUNCH 10""" | BIOPSY FINE CUT INSTRUMENTS | 2023-10-13 |
| G422BP1090 | "ROTO TISCHLER BIOPSY PUNCH 10""" | BIOPSY FINE CUT INSTRUMENTS | 2023-10-13 |
| G422BP0180 | "TISCHLER MORGAN BIOPSY PUNCH 10""" | BIOPSY FINE CUT INSTRUMENTS | 2023-10-13 |
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| 10381780428060 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-10 |
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| 10381780202523 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-09-28 |
| 10381780202486 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-09-28 |
| 10381780202479 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-09-28 |