HNR · Forceps, Ophthalmic
Ophthalmic · 21 CFR 886.4350 · Class 1
Overview
| Product Code | HNR |
|---|---|
| Device Name | Forceps, Ophthalmic |
| Regulation | 21 CFR 886.4350 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.
Cleared Devices (44)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K022835 | STEPHENS DISPOSABLE FORCEPS | Stephens Instruments | Nov 1, 2002 | SESE |
| K895434 | ALCON FOLDING FORCEPS | Alcon Laboratories | Dec 4, 1989 | SESE |
| K891487 | SOFT LENS FOLDING BLOCK | Western Medical Products, Inc. | Aug 15, 1989 | SESE |
| K893199 | PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR | Allergan Medical Optics | Jun 16, 1989 | SESE |
| K885230 | MCDONALD FOLDING FORCEPS | Alcon Laboratories | May 17, 1989 | SESE |
| K881049 | BRADBURY INTRAOCULAR RETINAL KIT CAT #200 | Microline Pentax, Inc. | Sep 12, 1988 | SESE |
| K883197 | IOL IMPLANTATION FORCEPS | D & D Surgical | Aug 22, 1988 | SESE |
| K880274 | ADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPS | Advanced Surgical Products, Inc. | Feb 5, 1988 | SESE |
| K864266 | OPHTHALMIC KNIFE & FORCEPS | Western Medical Products, Inc. | Nov 28, 1986 | SESE |
| K864183 | OPHTHALMIC SURGICAL INSTRUMENTS | Techno Ophthalmics Intl. | Nov 28, 1986 | SESE |
| K864071 | FAULKNER FORCEPS | Staar Surgical Co. | Nov 13, 1986 | SESE |
| K864003 | PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPS | Allergan, Inc. | Oct 31, 1986 | SESE |
| K863992 | THORNTON TITANIUM FORCEPS (VARIOUS TYPES) | Keeler Instruments, Inc. | Oct 31, 1986 | SESE |
| K863991 | THORTON TITANIUM NEEDLEHOLDERS(NO,W CATCH & STAND | Keeler Instruments, Inc. | Oct 31, 1986 | SESE |
| K863727 | FIXATION INSTRUMENTS | Medical Technology Development Corp. | Oct 31, 1986 | SESE |
| K861141 | MANUAL OPHTHALMIC SURGICAL INSTRUMENTS | CooperVision, Inc. | Apr 24, 1986 | SESE |
| K861057 | MANUAL OPHTHALMIC SURGICAL INSTRUMENTS | Precision-Cosmet Co., Inc. | Apr 24, 1986 | SESE |
| K860915 | STORZ/MAZZACCO LENS FORCEP | Storz Instrument Co. | Apr 15, 1986 | SESE |
| K854869 | INTRAOCULAR FORCEPS & SCISSORS | Mira, Inc. | Mar 5, 1986 | SESE |
| K852057 | ASCON SURGICAL INSTRUMENTS | Ascon Medical Instruments, Ltd. | Jun 27, 1985 | SESE |
| K851792 | 37-940 TO 37-944 VARIOUS NOYES OPHTHALMIC FORCEPS | Artiberia | May 30, 1985 | SESE |
| K851791 | 37-610 TO 37-880 VARIOUS OPHTHAL-FORCEPS | Artiberia | May 30, 1985 | SESE |
| K850119 | PHARMASEAL EYE PREP TRAY | American Pharmaseal Div. Ahsc | May 9, 1985 | SESE |
| K844129 | SHURE GRIP TYING FORCEPS | Mentor O & O, Inc. | Nov 21, 1984 | SESE |
| K843992 | CILCOR OPHTHALMIC INSTRUMENTS | Cilco, Inc. | Nov 21, 1984 | SESE |
| K842697 | ROOTMAN ORBITAL SURGERY INSTRUMENT SET | Downs Surgical , Ltd. | Aug 7, 1984 | SESE |
| K834355 | MICRO FORCEPS | Jedmed Instrument Co. | Mar 16, 1984 | SESE |
| K823174 | MICROSURGICAL INSTRUMENTS | Concept, Inc. | Nov 16, 1982 | SESE |
| K811658 | ANIS LENS IMPLANT FORCEPS #2 | American V. Mueller | Jun 26, 1981 | SESE |
| K803194 | FISHER-PICKERING INTRAOCULAR EYE MAGNET | Storz Instrument Co. | Feb 4, 1981 | SESE |
| K801467 | DODICK LENS HOLDING FORCEPS | Edward Weck, Inc. | Jul 28, 1980 | SESE |
| K801465 | GASKIN FRAGMENT FORCEPS(MFG. NON-STERILE | Edward Weck, Inc. | Jul 28, 1980 | SESE |
| K800368 | OPHTHALMIC FORCEPS | Edward Weck, Inc. | Mar 12, 1980 | SESE |
| K791986 | FIX. & LENS FOR. #'S 3510,3512,3248,3795 | Edward Weck, Inc. | Oct 4, 1979 | SESE |
| K771003 | LIEBERMAN POLACK DOUBLE CORNEAL FORCEPS | Edward Weck, Inc. | Jun 17, 1977 | SESE |
| K770105 | SHEPARD II, LENS FORCEP W/ LOCK | Edward Weck, Inc. | Jan 25, 1977 | SESE |
| K770101 | SHEPARD LENS FORCEP W/ IRRIGATOR & LOCK | Edward Weck, Inc. | Jan 25, 1977 | SESE |
| K770104 | BINKHORST LENS FORCEPS W/OUT IRRIGATOR | Edward Weck, Inc. | Jan 24, 1977 | SESE |
| K770102 | HERSHMAN LENS FORCEPS W/OUT IRRIGATOR | Edward Weck, Inc. | Jan 24, 1977 | SESE |
| K770100 | BINKHORST LENS FORCEP W/ IRRIGATOR | Edward Weck, Inc. | Jan 24, 1977 | SESE |
| K770099 | SHEPARD LENS FORCEP W/ IRRIGA W/OUT LOCK | Edward Weck, Inc. | Jan 24, 1977 | SESE |
| K770097 | HERSHMAN LENS FORCEPS WITH IRRIGATOR | Edward Weck, Inc. | Jan 24, 1977 | SESE |
| K761252 | WECK TYING FORCEP, CURVED TITANIUM | Edward Weck, Inc. | Dec 16, 1976 | SESE |
| K761251 | WECK TYING FORCEP, STRAIGHT TITANIUM | Edward Weck, Inc. | Dec 16, 1976 | SESE |
Top Applicants
- Edward Weck, Inc. — 14 clearances
- Western Medical Products, Inc. — 2 clearances
- Storz Instrument Co. — 2 clearances
- Keeler Instruments, Inc. — 2 clearances
- Artiberia — 2 clearances
