Implant, Absorbable, (Scleral Buckling Methods)
An Absorbable Scleral Buckling Implant is a surgically implanted device made from biodegradable material used in scleral buckling procedures to provide temporary inward indentation of the sclera, supporting closure of retinal breaks and reattachment of the retina in retinal detachment surgery. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) before marketing. It carries product code HQJ and is regulated under 21 CFR 886.3300, within the Ophthalmic medical specialty. It is classified as an implant.
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Basic Information
- Product Code
- HQJ
- Device Class
- FDA class 2
- Regulation Number
- 886.3300
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K896350 | TITAN AIR SPECTACLE FRAME | Dec 18, 1989 | Substantially Equivalent | Acces Intl. Eyewear |
| K884362 | LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD | Nov 29, 1988 | Substantially Equivalent | Bausch & Lomb Pharmaceutical, Inc. |
| K875014 | LABTICIAN RETINAL IMPLANTS | Feb 26, 1988 | Substantially Equivalent | Labtician Products, Inc. |
| K831773 | MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK | Aug 16, 1983 | Substantially Equivalent | Bcd Products, Inc. |
| K760550 | IMPLANT, SILICONE AND TANTALUM | Oct 05, 1976 | Substantially Equivalent | Medical Instrument Research Assoc., Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.