FDA product code HCZ: Forceps, Surgical, Gynecological
HCZ is the FDA product code for forceps, surgical, gynecological. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 24 510(k) submissions under HCZ, from 16 different applicants. The average 510(k) review took 146 days (median 68).
Classification
| Field | Value |
|---|---|
| Device name | Forceps, Surgical, Gynecological |
| Device class | Class II |
| Regulation | 21 CFR 884.4530 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HCZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 245 |
Compare with all 510(k) review times · Search every HCZ clearance
Top HCZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Thomasville Medical Assoc. | 6 | 1994-02-25 |
| Kinetic Medical Products | 3 | 1989-02-16 |
| Zinnanti Surgical Instruments, Inc. | 2 | 1989-03-17 |
| Fetzer Medical GmbH & Co. KG | 1 | 2018-05-08 |
| Integra LifeSciences Corporation | 1 | 2014-04-11 |
11 more applicants have HCZ clearances. See the full list in Caduvo.
Most recent HCZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K172661 | Fetzer Medical GmbH & Co. KG | Fetzer Medical Gynecological Forceps | 2018-05-08 | 245 |
| K134047 | Integra LifeSciences Corporation | JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS | 2014-04-11 | 101 |
| K092840 | Instrumed International, Inc. | INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL | 2009-12-03 | 79 |
| K944055 | Owens Precision Systems, Inc. | FORCEPS, SURGICAL GYNECOLOGICAL | 1994-09-20 | 32 |
| K941528 | Cook Urological, Inc. | PEARL PACKING FORCEPS | 1994-05-12 | 43 |
Recalls for HCZ devices
openFDA lists no recalls for product code HCZ.
Frequently asked questions
What is FDA product code HCZ?
HCZ is the FDA product code for forceps, surgical, gynecological. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is HCZ?
Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k).
How long does a 510(k) take for product code HCZ?
Across 24 cleared submissions the average was 146 days from receipt to decision (median 68).
Which companies have the most HCZ clearances?
Thomasville Medical Assoc. (6); Kinetic Medical Products (3); Zinnanti Surgical Instruments, Inc. (2); Fetzer Medical GmbH & Co. KG (1); Integra LifeSciences Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HCZ
- Run a recall and safety report across every HCZ manufacturer
- Watch product code HCZ 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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