FDA product code HQJ: Implant, Absorbable, (Scleral Buckling Methods)
HQJ is the FDA product code for implant, absorbable, (scleral buckling methods). It is a Class II device, regulated under 21 CFR 886.3300 and reviewed by the Ophthalmic panel. FDA has cleared 5 510(k) submissions under HQJ, from 5 different applicants. The average 510(k) review took 55 days (median 42).
Classification
| Field | Value |
|---|---|
| Device name | Implant, Absorbable, (Scleral Buckling Methods) |
| Device class | Class II |
| Regulation | 21 CFR 886.3300 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every HQJ clearance
Top HQJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Acces Intl. Eyewear | 1 | 1989-12-18 |
| Bausch & Lomb Pharmaceutical, Inc. | 1 | 1988-11-29 |
| Labtician Products, Inc. | 1 | 1988-02-26 |
| Bcd Products, Inc. | 1 | 1983-08-16 |
| Medical Instrument Research Assoc., Inc. | 1 | 1976-10-05 |
Most recent HQJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K896350 | Acces Intl. Eyewear | TITAN AIR SPECTACLE FRAME | 1989-12-18 | 42 |
| K884362 | Bausch & Lomb Pharmaceutical, Inc. | LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD | 1988-11-29 | 40 |
| K875014 | Labtician Products, Inc. | LABTICIAN RETINAL IMPLANTS | 1988-02-26 | 84 |
| K831773 | Bcd Products, Inc. | MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK | 1983-08-16 | 75 |
| K760550 | Medical Instrument Research Assoc., Inc. | IMPLANT, SILICONE AND TANTALUM | 1976-10-05 | 36 |
Recalls for HQJ devices
openFDA lists no recalls for product code HQJ.
Frequently asked questions
What is FDA product code HQJ?
HQJ is the FDA product code for implant, absorbable, (scleral buckling methods). It is a Class II device, regulated under 21 CFR 886.3300 and reviewed by the Ophthalmic panel.
What device class is HQJ?
Class II, regulation 21 CFR 886.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code HQJ?
Across 5 cleared submissions the average was 55 days from receipt to decision (median 42).
Which companies have the most HQJ clearances?
Acces Intl. Eyewear (1); Bausch & Lomb Pharmaceutical, Inc. (1); Labtician Products, Inc. (1); Bcd Products, Inc. (1); Medical Instrument Research Assoc., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HQJ
- Run a recall and safety report across every HQJ manufacturer
- Watch product code HQJ 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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