Scissors, Iris
FDA 510(k) K770019 · J. Sklar Mfg. Co., Inc.
510(k) numberK770019
Submission
- Device name
- Scissors, Iris
- Applicant
- J. Sklar Mfg. Co., Inc.
Mchenry, IL, US - Received
- January 5, 1977
- Decision date
- January 12, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HNF – Scissors, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HNF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022840 | Stephens Disposable ScissorsHNF · Traditional | Stephens Instruments | 11/01/2002SE |
| K897093 | Intraocular Microscissors by Means of Gamma Radia.HNF · Traditional | Microline Pentax, Inc. | 04/04/1990SE |
| K873099 | Manual Ophthalmic Surgical InstrumentsHNF · Traditional | Alcon Laboratories | 09/04/1987SE |
| K851768 | 13-550,13-560 Wescott Scossors (Eye)HNF · Traditional | Artiberia | 06/20/1985SE |
| K822151 | Surgical Instruments Represent. 4 ClassHNF · Traditional | Robert I. Chien & Assoc., Inc. | 08/19/1982SE |
| K821290 | Littauer Scissors 5 1/2HNF · Traditional | Conphar, Inc. | 05/28/1982SE |
| K821286 | Iris Scissors Straight 4 1/2HNF · Traditional | Conphar, Inc. | 05/28/1982SE |
| K811245 | Ophthalmic ScissorsHNF · Traditional | Keeler Instruments, Inc. | 07/31/1981SE |
| K770041 | Scissors, Strabismus, 4 CurvedHNF · Traditional | J. Sklar Mfg. Co., Inc. | 01/14/1977SE |
| K770040 | Scissors, Strabimus, 4 StraightHNF · Traditional | J. Sklar Mfg. Co., Inc. | 01/14/1977SE |
More from J. Sklar Mfg. Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K843693 | Jacobs High Vacuum Suction Unit 05-2570BTA · Traditional | 10/31/1984SE |
| K842112 | Tischler Cervical Biopsy Punch ForcepsHFB · Traditional | 07/03/1984SE |
| K842111 | Kogan Endospeculum 9-1/2HTZ · Traditional | 06/19/1984SE |
| K822448 | Scissors, VariousFZT · Traditional | 09/14/1982SE |
| K802458 | Kevorkian-Younge Biopsy Curette #90-6611HFB · Traditional | 01/12/1981SE |
| K802457 | Kevorkian-Younge Biopsy Punch, #90-6610HFB · Traditional | 01/12/1981SE |
| K801273 | Magill Catheter Intro. ForcepsKOA · Traditional | 07/28/1980SE |
| K800441 | Rudd-Clinic Hemorrhoidal ForcepsKOA · Traditional | 04/08/1980SE |
| K790577 | Hemorrhoidal LigatorHCF · Traditional | 04/23/1979SE |
| K772230 | Cannula, Perfusion, Fallopian TubeLKF · Traditional | 01/03/1978SE |
Questions and answers
When was Scissors, Iris cleared by the FDA?
Scissors, Iris (K770019) received a 510(k) decision of Substantially Equivalent on January 12, 1977, 7 days after the submission was received.
What is the product code of K770019?
The FDA product code is HNF – Scissors, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.