Product code HNC
- Device name
- Specula, Ophthalmic
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.4350
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K022836 | STEPHENS DISPOSABLE SPECULUM | Stephens Instruments | 2002-11-01 |
| K981235 | OCULOSTAT | Laser Center Dev. Corp. | 1998-07-15 |
| K964289 | EYE FIXATION SPECULUM | Eyefix, Inc. | 1996-12-17 |
| K863989 | THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER) | Keeler Instruments, Inc. | 1986-10-31 |
| K863664 | OPHTHALMIC SURGICAL SPECULUM | Myocure, Inc. | 1986-09-25 |
| K843196 | VISITEC EYE SPECULUM | Visitec Co. | 1984-10-05 |
| K830430 | EYELID SPECULUM | Douglas C. Mckee & Co. | 1983-06-10 |
| K801969 | ASNIS GUIDED SCREW SYSTEMS | Howmedica Corp. | 1980-08-27 |
| K760847 | FELDSTEIN BLEPHAROPLASTY CLIP SHARP P | V. Mueller O.V. Baxter Healthcare Corp. | 1976-11-02 |
| K760848 | FELDSTEIN BLEPHAROPLASTY CLIP RECTANGU | V. Mueller O.V. Baxter Healthcare Corp. | 1976-11-02 |
| K760849 | FELDSTEIN BLEPHAROSTOMY CLIP SQUARE | V. Mueller O.V. Baxter Healthcare Corp. | 1976-11-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04251047900655 | Lieberman Eye Speculum | A1 Medical GmbH | 2026-05-29 |
| 04251047900679 | Lieberman Eye Speculum | A1 Medical GmbH | 2026-05-29 |
| 04251047900686 | Lieberman Eye Speculum | A1 Medical GmbH | 2026-05-29 |
| 04251047932373 | Mod. Krumeich Eye Speculum | A1 Medical GmbH | 2026-05-29 |
| 04251047900174 | Kratz-Barraquer Wire Speculum | A1 Medical GmbH | 2026-05-29 |
| G006D1053250 | Infant Wire Speculum, Blade Size 5mm Close | DAUD JEE MFG. CO | 2022-12-13 |
| G006D1055000 | WILLIAMS EYE SPECULUM SMALL | DAUD JEE MFG. CO | 2022-12-13 |
| G006D1053300 | Infant Wire Speculum Blades size 6mm, Solid | DAUD JEE MFG. CO | 2022-12-13 |
| G006D1053400 | Alphonso speculum | DAUD JEE MFG. CO | 2022-12-13 |
| G006D1053500 | INFANT LID SPECULUM. | DAUD JEE MFG. CO | 2022-12-13 |
| G006D1053550 | BARRAQUER WIRE SPECULUM INFANT | DAUD JEE MFG. CO | 2022-12-13 |
| G006D1054010 | COOK EYE SPECULUM, SM #1 SOLID | DAUD JEE MFG. CO | 2022-12-13 |
| G006D1054020 | COOK EYE SPECULUM, MD #2 SOLID | DAUD JEE MFG. CO | 2022-12-13 |
| G006D1054030 | COOK EYE SPECULUM, LG #3 SOLID | DAUD JEE MFG. CO | 2022-12-13 |
| G006D1054060 | MURDOCH EYE SPECULUM, MD #2 | DAUD JEE MFG. CO | 2022-12-13 |
| G006D1054070 | MURDOCH EYE SPECULUM, LG #3 | DAUD JEE MFG. CO | 2022-12-13 |
| G006D1054110 | MELLINGER EYE SPECULUM | DAUD JEE MFG. CO | 2022-12-13 |
| G006D1053200 | Infant Wire Speculum | DAUD JEE MFG. CO | 2022-12-13 |
| G006D1053100 | FRANKEL INFANT EYE SPECULUM ADJUSTABLE | DAUD JEE MFG. CO | 2022-12-13 |
| G006D1053020 | SAUER LID SPECULUM, FOR PREMATURE INFANTS | DAUD JEE MFG. CO | 2022-12-13 |
| G006D1051810 | LIEBERMAN MAYOSHI WITH ASPIRATION 9MM BLADE | DAUD JEE MFG. CO | 2022-12-13 |
| G006D1051800 | LIEBERMAN ASPIR SPEC CHU SOLID 15MM | DAUD JEE MFG. CO | 2022-12-13 |
| G006D1051790 | Lieberman Style, Aspirating Adjustable mechanism | DAUD JEE MFG. CO | 2022-12-13 |
| G006D1051750 | LIEBERMAN ASPIR SPEC V-WIRE 15MM | DAUD JEE MFG. CO | 2022-12-13 |
| G006D1051730 | LIEBERMAN ASPIR SPEC ROUND WIRE11MM | DAUD JEE MFG. CO | 2022-12-13 |
| G006D1051710 | LIEBERMAN ASPIR SPEC K-WIRE 15MM | DAUD JEE MFG. CO | 2022-12-13 |
| G006D1012400 | BANGERTER SPECULUM 10MM | DAUD JEE MFG. CO | 2022-12-13 |
| G006D1012300 | BANGERTER SPECULUM 15MM | DAUD JEE MFG. CO | 2022-12-13 |
| G006D101159600 | LIEBERMAN TENNAT SPECULUM OPEN BLADES | DAUD JEE MFG. CO | 2022-12-13 |
| G006D101159500 | WEISS EYE SPECULUM | DAUD JEE MFG. CO | 2022-12-13 |