Forceps, Biopsy, Gynecological
The Gynecological Biopsy Forceps is a manually operated instrument used during pelvic examination or colposcopy to obtain small tissue samples from the cervix, vagina, or uterine cavity for histopathological analysis. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from 510(k) premarket notification. The product code is HFB, regulated under 21 CFR 884.4530, within the Obstetrics/Gynecology specialty. No special risk flags apply.
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Basic Information
- Product Code
- HFB
- Device Class
- FDA class 1
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 22 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K011488 | SPIRABRUSH CX BIOPSY INSTRUMENT | Feb 22, 2002 | Substantially Equivalent | Trylon Corp. |
| K944444 | CIT BIOPSY PUNCHES | Sep 29, 1995 | Substantially Equivalent | Chirurgische Instrumente |
| K930773 | SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS | Jul 28, 1994 | Substantially Equivalent | Symbiosis Corp. |
| K933767 | FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY | May 26, 1994 | Substantially Equivalent | Mahe-Medizintechnik |
| K926595 | OWENS BIOPSY FORCEPS | May 25, 1994 | Substantially Equivalent | Owens Industries, Inc. |
| K926527 | ROTO FIT BIOPSY FORCEPS | Feb 25, 1994 | Substantially Equivalent | Thomasville Medical Assoc. |
| K930036 | THOMAS MEDICAL BIOPSY FORCEPS | Feb 24, 1994 | Substantially Equivalent | Thomasville Medical Assoc. |
| K926538 | TISCHLER BIOPSY FORCEPS | Feb 24, 1994 | Substantially Equivalent | Thomasville Medical Assoc. |
| K924224 | OWENS BIOPSY FORCEPS | Feb 04, 1994 | Substantially Equivalent | Owens Precision Systems, Inc. |
| K902049 | CROAK OVARIAN BIOPSY FORCEP | Jun 07, 1990 | Substantially Equivalent | Gynescope Corp. |
| K895303 | EVER-SHARP BIOPSY FORCEPS | Jan 16, 1990 | Substantially Equivalent | Southwest Medical Mfg., Inc. |
| K891043 | ROTO FIT BIOPSY FORCEPS | Mar 22, 1989 | Substantially Equivalent | Zinnanti Surgical Instruments, Inc. |
| K891034 | TISCHLER BIOPSY FORCEPS | Mar 17, 1989 | Substantially Equivalent | Zinnanti Surgical Instruments, Inc. |
| K891027 | ZSI BIOPSY FORCEPS | Mar 17, 1989 | Substantially Equivalent | Zinnanti Surgical Instruments, Inc. |
| K890380 | CERVICAL BIOPSY FORCEPS | Feb 27, 1989 | Substantially Equivalent | Kinetic Medical Products |
| K852357 | GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP | Jul 05, 1985 | Substantially Equivalent | Gyneco, Inc. |
| K851110 | GAYLOR-THOMS UTERINE BIOPSY FORCEPS 1810-144 PCS. | Apr 08, 1985 | Substantially Equivalent | The Huxley Instrument Corp. |
| K842112 | TISCHLER CERVICAL BIOPSY PUNCH FORCEPS | Jul 03, 1984 | Substantially Equivalent | J. Sklar Mfg. Co., Inc. |
| K840352 | CIN-SHEAR | Apr 05, 1984 | Substantially Equivalent | Roland J. Zwick, Inc. |
| K820519 | BIOPSER | Apr 29, 1982 | Substantially Equivalent | Advanced Biomedical Instruments |
| K802458 | KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611 | Jan 12, 1981 | Substantially Equivalent | J. Sklar Mfg. Co., Inc. |
| K802457 | KEVORKIAN-YOUNGE BIOPSY PUNCH, #90-6610 | Jan 12, 1981 | Substantially Equivalent | J. Sklar Mfg. Co., Inc. |
FEI Numbers
This FDA classification entry is associated with 160 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 160 registration numbers. Click on an entry to view related FDA registrations.