Bradbury Intraocular Retinal Kit Cat #200
FDA 510(k) K881049 · Microline Pentax, Inc.
510(k) numberK881049
Submission
- Device name
- Bradbury Intraocular Retinal Kit Cat #200
- Applicant
- Microline Pentax, Inc.
Devers, MA, US - Received
- March 11, 1988
- Decision date
- September 12, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HNR – Forceps, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HNR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022835 | Stephens Disposable ForcepsHNR · Traditional | Stephens Instruments | 11/01/2002SE |
| K895434 | Alcon Folding ForcepsHNR · Traditional | Alcon Laboratories | 12/04/1989SE |
| K891487 | Soft Lens Folding BlockHNR · Traditional | Western Medical Products, Inc. | 08/15/1989SE |
| K893199 | Phaco-Injector(Tm) Intraocular Lens Implant InstrHNR · Traditional | Allergan Medical Optics | 06/16/1989SE |
| K885230 | Mcdonald Folding ForcepsHNR · Traditional | Alcon Laboratories | 05/17/1989SE |
| K883197 | Iol Implantation ForcepsHNR · Traditional | D & D Surgical | 08/22/1988SE |
| K880274 | Advanced Surgical Products Scleral Plug ForcepsHNR · Traditional | Advanced Surgical Products, Inc. | 02/05/1988SE |
| K864266 | Ophthalmic Knife & ForcepsHNR · Traditional | Western Medical Products, Inc. | 11/28/1986SE |
| K864183 | Ophthalmic Surgical InstrumentsHNR · Traditional | Techno Ophthalmics Intl. | 11/28/1986SE |
| K864071 | Faulkner ForcepsHNR · Traditional | Staar Surgical Co. | 11/13/1986SE |
More from Staar Surgical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K013695 | Microline Inc. Reusable Laparoscopic Clip Applier with Implantable Titanium Clips, Model…GCJ · Traditional | 01/08/2002SE |
| K982984 | Accushear Laparoscopic Surgical InstrumentsGEI · Traditional | 10/21/1998SE |
| K981389 | Disposable Re-New ForcepsGEI · Traditional | 05/29/1998SE |
| K981188 | Electrosurgical Cautery ProbesGEI · Traditional | 05/20/1998SE |
| K980758 | 3 MM Selec-Tip Laparoscopic ScissorsGEI · Traditional | 03/27/1998SE |
| K974066 | Re-New Forceps Laparoscopic Surgical TipsGEI · Traditional | 01/22/1998SE |
| K970826 | Selecta-Tip Laparoscopic ScissorsGEI · Traditional | 03/28/1997SE |
| K962119 | Re-New Laparoscopic InstrumentsGEI · Traditional | 08/09/1996SE |
| K932648 | Quick Switch Laparoscopic InstrumentsGCJ · Traditional | 10/12/1993SE |
| K897093 | Intraocular Microscissors by Means of Gamma Radia.HNF · Traditional | 04/04/1990SE |
Questions and answers
When was Bradbury Intraocular Retinal Kit Cat #200 cleared by the FDA?
Bradbury Intraocular Retinal Kit Cat #200 (K881049) received a 510(k) decision of Substantially Equivalent on September 12, 1988, 185 days after the submission was received.
What is the product code of K881049?
The FDA product code is HNR – Forceps, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.