Iris Scissors Straight 4 1/2
FDA 510(k) K821286 · Conphar, Inc.
510(k) numberK821286
Submission
- Device name
- Iris Scissors Straight 4 1/2
- Applicant
- Conphar, Inc.
Mchenry, IL, US - Received
- May 4, 1982
- Decision date
- May 28, 1982
- 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 |
| 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 |
|---|---|---|
| K821825 | Conphar Silicone Feeding TubeKNT · Traditional | 08/10/1982SE |
| K821354 | Conphar Mayo Hegar Needle HolderGDF · Traditional | 06/03/1982SE |
| K821295 | Olsen Hegar Needle HoldersGDF · Traditional | 06/03/1982SE |
| K821289 | Mayo-Hegar Needle HolderGDF · Traditional | 06/03/1982SE |
| K821298 | Backhaus Clamp, 3 1/2HTD · Traditional | 05/28/1982SE |
| K821294 | Tonsil Scissors Straight 5 1/2EGN · Traditional | 05/28/1982SE |
| K821293 | Backhaus Clamp, 5 1/4HTD · Traditional | 05/28/1982SE |
| K821292 | Tonsil Scissors 7EGN · Traditional | 05/28/1982SE |
| K821290 | Littauer Scissors 5 1/2HNF · Traditional | 05/28/1982SE |
| K821285 | Splinter Forceps 4 1/2EFL · Traditional | 05/28/1982SE |
Questions and answers
When was Iris Scissors Straight 4 1/2 cleared by the FDA?
Iris Scissors Straight 4 1/2 (K821286) received a 510(k) decision of Substantially Equivalent on May 28, 1982, 24 days after the submission was received.
What is the product code of K821286?
The FDA product code is HNF – Scissors, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.