FDA product code HIN: Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
HIN is the FDA product code for coagulator-cutter, endoscopic, bipolar (and accessories). It is a Class II device, regulated under 21 CFR 884.4150 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 16 510(k) submissions under HIN, from 12 different applicants. The average 510(k) review took 163 days (median 96).
Classification
| Field | Value |
|---|---|
| Device name | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) |
| Device class | Class II |
| Regulation | 21 CFR 884.4150 |
| 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 HIN clearance
Top HIN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 2 | 2013-06-26 |
| Gyrus Acmi, Inc. | 2 | 2012-12-05 |
| Richard Wolf Medical Instruments Corp. | 2 | 1999-04-16 |
| Kli | 2 | 1978-09-14 |
| Olympus Winter & Ibe GmbH | 1 | 2014-11-21 |
7 more applicants have HIN clearances. See the full list in Caduvo.
Most recent HIN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K142525 | Olympus Winter & Ibe GmbH | PK Lap Loop | 2014-11-21 | 74 |
| K130305 | Lina Medical Aps | LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE | 2013-07-24 | 169 |
| K122983 | KARL STORZ Endoscopy-America, Inc. | KSEA BIPOLAR ELECTRODE | 2013-06-26 | 273 |
| K122605 | Gyrus Acmi, Inc. | PKS BILL | 2012-12-05 | 100 |
| K113080 | Mectra Labs, Inc. | TUBALGATOR | 2012-06-29 | 255 |
Recalls for HIN devices
openFDA lists no recalls for product code HIN.
Frequently asked questions
What is FDA product code HIN?
HIN is the FDA product code for coagulator-cutter, endoscopic, bipolar (and accessories). It is a Class II device, regulated under 21 CFR 884.4150 and reviewed by the Obstetrics and Gynecology panel.
What device class is HIN?
Class II, regulation 21 CFR 884.4150. Typical premarket route: 510(k).
How long does a 510(k) take for product code HIN?
Across 16 cleared submissions the average was 163 days from receipt to decision (median 96).
Which companies have the most HIN clearances?
KARL STORZ Endoscopy-America, Inc. (2); Gyrus Acmi, Inc. (2); Richard Wolf Medical Instruments Corp. (2); Kli (2); Olympus Winter & Ibe GmbH (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HIN
- Run a recall and safety report across every HIN manufacturer
- Watch product code HIN 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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