FDA product code HFB: Forceps, Biopsy, Gynecological
HFB is the FDA product code for forceps, biopsy, gynecological. It is a Class I device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 22 510(k) submissions under HFB, from 16 different applicants. The average 510(k) review took 210 days (median 96). FDA has posted 1 recall for HFB devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Forceps, Biopsy, Gynecological |
| Device class | Class I |
| Regulation | 21 CFR 884.4530 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HFB clearance
Top HFB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Thomasville Medical Assoc. | 3 | 1994-02-25 |
| Zinnanti Surgical Instruments, Inc. | 3 | 1989-03-22 |
| J. Sklar Mfg. Co., Inc. | 3 | 1984-07-03 |
| Trylon Corp. | 1 | 2002-02-22 |
| Chirurgische Instrumente | 1 | 1995-09-29 |
11 more applicants have HFB clearances. See the full list in Caduvo.
Most recent HFB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K011488 | Trylon Corp. | SPIRABRUSH CX BIOPSY INSTRUMENT | 2002-02-22 | 283 |
| K944444 | Chirurgische Instrumente | CIT BIOPSY PUNCHES | 1995-09-29 | 413 |
| K930773 | Symbiosis Corp. | SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS | 1994-07-28 | 527 |
| K933767 | Mahe-Medizintechnik | FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY | 1994-05-26 | 301 |
| K926595 | Owens Industries, Inc. | OWENS BIOPSY FORCEPS | 1994-05-25 | 623 |
Recalls for HFB devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-12-03.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code HFB?
HFB is the FDA product code for forceps, biopsy, gynecological. It is a Class I device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is HFB?
Class I, regulation 21 CFR 884.4530. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HFB?
Across 22 cleared submissions the average was 210 days from receipt to decision (median 96).
Which companies have the most HFB clearances?
Thomasville Medical Assoc. (3); Zinnanti Surgical Instruments, Inc. (3); J. Sklar Mfg. Co., Inc. (3); Trylon Corp. (1); Chirurgische Instrumente (1).
Have HFB devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-12-03.
Next steps
- Run an FDA pathway report with predicate devices for product code HFB
- Run a recall and safety report across every HFB manufacturer
- Watch product code HFB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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