FDA product code HFI: Coagulator, Culdoscopic (And Accessories)
HFI is the FDA product code for coagulator, culdoscopic (and accessories). It is a Class II device, regulated under 21 CFR 884.4160 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 8 510(k) submissions under HFI, from 7 different applicants. The average 510(k) review took 361 days (median 434).
Classification
| Field | Value |
|---|---|
| Device name | Coagulator, Culdoscopic (And Accessories) |
| Device class | Class II |
| Regulation | 21 CFR 884.4160 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HFI clearance
Top HFI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zinnanti Surgical Instruments, Inc. | 2 | 1994-06-07 |
| Endoplus | 1 | 2015-12-23 |
| Cook Urological, Inc. | 1 | 1994-03-11 |
| Endo Technic Corp. | 1 | 1994-02-28 |
| Snowden-Pencer | 1 | 1994-02-28 |
2 more applicants have HFI clearances. See the full list in Caduvo.
Most recent HFI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K151567 | Endoplus | ENDOPLUS hand-held laparoscopic instruments | 2015-12-23 | 196 |
| K925960 | Zinnanti Surgical Instruments, Inc. | FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE | 1994-06-07 | 560 |
| K925957 | Zinnanti Surgical Instruments, Inc. | SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE | 1994-06-07 | 560 |
| K936026 | Cook Urological, Inc. | COOK LAPAROSCOPIC MINI RETRACTOR SET | 1994-03-11 | 84 |
| K925114 | Endo Technic Corp. | LAPAROSCOPIC INSTRUMENTS | 1994-02-28 | 507 |
Recalls for HFI devices
openFDA lists no recalls for product code HFI.
Frequently asked questions
What is FDA product code HFI?
HFI is the FDA product code for coagulator, culdoscopic (and accessories). It is a Class II device, regulated under 21 CFR 884.4160 and reviewed by the Obstetrics and Gynecology panel.
What device class is HFI?
Class II, regulation 21 CFR 884.4160. Typical premarket route: 510(k).
How long does a 510(k) take for product code HFI?
Across 8 cleared submissions the average was 361 days from receipt to decision (median 434).
Which companies have the most HFI clearances?
Zinnanti Surgical Instruments, Inc. (2); Endoplus (1); Cook Urological, Inc. (1); Endo Technic Corp. (1); Snowden-Pencer (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HFI
- Run a recall and safety report across every HFI manufacturer
- Watch product code HFI 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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