Pearce Corneal Trephine
FDA 510(k) K812723 · Visitec Co.
510(k) numberK812723
Submission
- Device name
- Pearce Corneal Trephine
- Applicant
- Visitec Co.
Mchenry, IL, US - Received
- September 28, 1981
- Decision date
- October 13, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HRH – Trephine, Manual, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HRH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022843 | Gayheart Corneal Excision DeviceHRH · Traditional | Stephens Instruments | 11/01/2002SE |
| K931792 | ArthroscopeHRH · Traditional | Intramed Laboratories, Inc. | 06/13/1994SE |
| K873918 | Head & Chin RestsHRH · Traditional | Richmond Products, Inc. | 10/28/1987SE |
| K864520 | Barron Rotary Blade Trephine Using Hessburg-BarronHRH · Traditional | Precision Instruments, Inc. | 01/20/1987SE |
| K862524 | Deknatel (R) TrephineHRH · Traditional | Deknatel, Inc. | 08/11/1986SE |
| K861825 | Corneal Transplant Trephine Disposable BladeHRH · Traditional | Storz Instrument Co. | 06/09/1986SE |
| K860648 | Barron Twin Blade Trephine for EppikaratophakiaHRH · Traditional | Precision Instruments, Inc. | 03/25/1986SN |
| K843646 | Steinway Micro-Kerato-TrephineHRH · Traditional | Steinway Instrument Co., Inc. | 01/03/1985SE |
| K843048 | Ring Supported Trephine for Cornea TransHRH · Traditional | Precision Instruments, Inc. | 10/05/1984SE |
| K781411 | Corneal Cutter and AccessoriesHRH · Traditional | Codman & Shurtleff, Inc. | 09/20/1978SE |
More from Codman & Shurtleff, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K953394 | Visitec Collar Button Catheter {Griffiths}LZU · Traditional | 10/12/1995SE |
| K945114 | Visitec Scleral PlugLXP · Traditional | 02/23/1995SE |
| K945738 | Visiflex Ophthalmic Surgical Incise DrapeHMT · Traditional | 02/14/1995SE |
| K945172 | Visitec Silicone Retinal Implants/ExplantsHQX · Traditional | 01/17/1995SE |
| K942234 | Visitec Precise-PointGAP · Traditional | 07/12/1994SE |
| K934269 | Fiberoptic Illuminated InstrumentsHJM · Traditional | 05/17/1994SE |
| K940210 | Visitec Eye PadEFQ · Traditional | 03/07/1994SE |
| K933872 | Visi-Spear Eye SpongeHOZ · Traditional | 12/27/1993SE |
| K923972 | Ophthalmic Fluid Distribution SetsFPK · Traditional | 11/04/1992SE |
| K922530 | Visitec Microsurgical SutureGAR · Traditional | 10/20/1992SE |
Questions and answers
When was Pearce Corneal Trephine cleared by the FDA?
Pearce Corneal Trephine (K812723) received a 510(k) decision of Substantially Equivalent on October 13, 1981, 15 days after the submission was received.
What is the product code of K812723?
The FDA product code is HRH – Trephine, Manual, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.