13-550,13-560 Wescott Scossors (Eye)
FDA 510(k) K851768 · Artiberia
510(k) numberK851768
Submission
- Device name
- 13-550,13-560 Wescott Scossors (Eye)
- Applicant
- Artiberia
San Antonio, TX, US - Received
- April 25, 1985
- Decision date
- June 20, 1985
- 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 |
| 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 |
| K770019 | Scissors, IrisHNF · Traditional | J. Sklar Mfg. Co., Inc. | 01/12/1977SE |
More from J. Sklar Mfg. Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K851745 | 1-100 Universal Set Otoscope & Larynx Exploraton BERA · Traditional | 08/29/1985SE |
| K851786 | 27-230 to 27-234 Various Cast Breakers, WolfLGG · Traditional | 07/09/1985SE |
| K851730 | 2710 to 2935 Various Pliers for Orthodontics/ProstEJY · Traditional | 07/02/1985SE |
| K851729 | 2620/1 to 2635/2 Various Dental Crown ScissorsEIR · Traditional | 07/02/1985SE |
| K851727 | 2020-1/2 to 2220 Various Dental Wax & Modelling CaEIK · Traditional | 07/02/1985SE |
| K851726 | 1760/1 to 2010/34 Various Dental Filling InstrumenEIY · Traditional | 07/02/1985SE |
| K851724 | 1410/1 to 1435/13 Various Probes & ExplorersEKB · Traditional | 07/02/1985SE |
| K851723 | 1300/10 to 1305/89-92 Various Cutting InstrumentsEKD · Traditional | 07/02/1985SE |
| K851722 | 1285/5 to 1295 Various Types of Dental ExcavatorsEKC · Traditional | 07/02/1985SE |
| K851721 | 1200/1 to 1240/15 Various Types of Dental ScalersEMN · Traditional | 07/02/1985SE |
Questions and answers
When was 13-550,13-560 Wescott Scossors (Eye) cleared by the FDA?
13-550,13-560 Wescott Scossors (Eye) (K851768) received a 510(k) decision of Substantially Equivalent on June 20, 1985, 56 days after the submission was received.
What is the product code of K851768?
The FDA product code is HNF – Scissors, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.