Scissors, Ophthalmic
Ophthalmic Scissors are handheld cutting instruments designed for use in eye surgery, used to incise, dissect, and trim tissue structures within or around the eye. This device is FDA Class 1 (lowest risk), meaning it is subject to general controls only and does not require premarket notification or approval. It carries product code HNF and is regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty.
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Basic Information
- Product Code
- HNF
- Device Class
- FDA class 1
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K022840 | STEPHENS DISPOSABLE SCISSORS | Nov 01, 2002 | Substantially Equivalent | Stephens Instruments |
| K897093 | INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA. | Apr 04, 1990 | Substantially Equivalent | Microline Pentax, Inc. |
| K873099 | MANUAL OPHTHALMIC SURGICAL INSTRUMENTS | Sep 04, 1987 | Substantially Equivalent | Alcon Laboratories |
| K851768 | 13-550,13-560 WESCOTT SCOSSORS (EYE) | Jun 20, 1985 | Substantially Equivalent | Artiberia |
| K822151 | SURGICAL INSTRUMENTS REPRESENT. 4 CLASS | Aug 19, 1982 | Substantially Equivalent | Robert I. Chien & Assoc., Inc. |
| K821290 | LITTAUER SCISSORS 5 1/2 | May 28, 1982 | Substantially Equivalent | Conphar, Inc. |
| K821286 | IRIS SCISSORS STRAIGHT 4 1/2 | May 28, 1982 | Substantially Equivalent | Conphar, Inc. |
| K811245 | OPHTHALMIC SCISSORS | Jul 31, 1981 | Substantially Equivalent | Keeler Instruments, Inc. |
| K770041 | SCISSORS, STRABISMUS, 4 CURVED | Jan 14, 1977 | Substantially Equivalent | J. Sklar Mfg. Co., Inc. |
| K770040 | SCISSORS, STRABIMUS, 4 STRAIGHT | Jan 14, 1977 | Substantially Equivalent | J. Sklar Mfg. Co., Inc. |
| K770019 | SCISSORS, IRIS | Jan 12, 1977 | Substantially Equivalent | J. Sklar Mfg. Co., Inc. |
| K760326 | SURGICAL INSTRUMENTS, OPTHALMIC | Aug 04, 1976 | Substantially Equivalent | Depuy, Inc. |
| K760190 | SCISSORS, IRIS STRAIGHT | Aug 04, 1976 | Substantially Equivalent | V. Mueller O.V. Baxter Healthcare Corp. |
| K760188 | SCISSORS, MICRO IRIS CURVED | Aug 04, 1976 | Substantially Equivalent | V. Mueller O.V. Baxter Healthcare Corp. |
| K760185 | SCISSORS, MICRO IRIS STRAIGHT | Aug 04, 1976 | Substantially Equivalent | V. Mueller O.V. Baxter Healthcare Corp. |
FEI Numbers
This FDA classification entry is associated with 261 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 261 registration numbers. Click on an entry to view related FDA registrations.