FDA product code HOB: Clamp, Muscle, Ophthalmic
HOB is the FDA product code for clamp, muscle, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. FDA has cleared 3 510(k) submissions under HOB, from 3 different applicants. The average 510(k) review took 52 days (median 52).
Classification
| Field | Value |
|---|---|
| Device name | Clamp, Muscle, Ophthalmic |
| 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 HOB clearance
Top HOB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Imm Enterprises , Ltd. | 1 | 1984-03-16 |
| Truline Instruments, Inc. | 1 | 1984-03-16 |
| Varian Assoc., Inc. | 1 | 1978-06-30 |
Most recent HOB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K840101 | Truline Instruments, Inc. | EYE SURGERY INSTRUMENT | 1984-03-16 | 66 |
| K840310 | Imm Enterprises , Ltd. | CATEGORY 6 OPTHALMIC DEVICES | 1984-03-16 | 52 |
| K780851 | Varian Assoc., Inc. | CHARLES ENDOCOAGULATOR ACCESSORY FOR ARC | 1978-06-30 | 39 |
Recalls for HOB devices
openFDA lists no recalls for product code HOB.
Frequently asked questions
What is FDA product code HOB?
HOB is the FDA product code for clamp, muscle, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is HOB?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HOB?
Across 3 cleared submissions the average was 52 days from receipt to decision (median 52).
Which companies have the most HOB clearances?
Imm Enterprises , Ltd. (1); Truline Instruments, Inc. (1); Varian Assoc., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HOB
- Run a recall and safety report across every HOB manufacturer
- Watch product code HOB 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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