Ophthalmic Scissors
FDA 510(k) K811245 · Keeler Instruments, Inc.
510(k) numberK811245
Submission
- Device name
- Ophthalmic Scissors
- Applicant
- Keeler Instruments, Inc.
Mchenry, IL, US - Received
- May 4, 1981
- Decision date
- July 31, 1981
- 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 |
| 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 |
|---|---|---|
| K181143 | Keeler TonoCare TonometerHKX · Traditional | 02/08/2019SE |
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| K093298 | Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000HKX · Traditional | 12/10/2010SE |
| K100500 | PSL Classic Slit LampHJO · Traditional | 03/09/2010SE |
| K062412 | CryomaticHRN · Traditional | 11/06/2006SE |
| K060822 | Vantage Indirect OphthalmoscopeHLI · Special | 05/23/2006SE |
| K032087 | Keeler Wide Angle Ophthalmoscope Model 1130-P-5004HLJ · Traditional | 11/26/2003SE |
| K992954 | Keeler Cryo Master & ProbesHRN · Traditional | 12/21/1999SE |
| K990257 | Keeler Pulsair 3000 Non Contact TonometerHKX · Traditional | 03/25/1999SE |
| K973064 | Keeler Tearscope-PlusHJO · Traditional | 04/07/1998SE |
Questions and answers
When was Ophthalmic Scissors cleared by the FDA?
Ophthalmic Scissors (K811245) received a 510(k) decision of Substantially Equivalent on July 31, 1981, 88 days after the submission was received.
What is the product code of K811245?
The FDA product code is HNF – Scissors, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.