FDA product code HOC: Clip, Iris Retractor
HOC is the FDA product code for clip, iris retractor. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. FDA has cleared 2 510(k) submissions under HOC, from 2 different applicants. The average 510(k) review took 97 days (median 97).
Classification
| Field | Value |
|---|---|
| Device name | Clip, Iris Retractor |
| Device class | Class I |
| Regulation | 21 CFR 886.4350 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HOC clearance
Top HOC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Technical Products | 1 | 1987-08-10 |
| Phakosystems, Inc. | 1 | 1983-06-02 |
Most recent HOC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K871474 | Medical Technical Products | PART #860070 ULTRAPAK & #860075 ULTRAPAK | 1987-08-10 | 118 |
| K830871 | Phakosystems, Inc. | PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION | 1983-06-02 | 76 |
Recalls for HOC devices
openFDA lists no recalls for product code HOC.
Frequently asked questions
What is FDA product code HOC?
HOC is the FDA product code for clip, iris retractor. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is HOC?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HOC?
Across 2 cleared submissions the average was 97 days from receipt to decision (median 97).
Which companies have the most HOC clearances?
Medical Technical Products (1); Phakosystems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HOC
- Run a recall and safety report across every HOC manufacturer
- Watch product code HOC 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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