Beaver Cataract Cyroxtractor
FDA 510(k) K781338 · Edward Weck, Inc.
510(k) numberK781338
Submission
- Device name
- Beaver Cataract Cyroxtractor
- Applicant
- Edward Weck, Inc.
Mchenry, IL, US - Received
- August 4, 1978
- Decision date
- February 12, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HPS – Unit, Cryophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4170
- Specialty
- Ophthalmic
Other 510(k)s with product code HPS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K202038 | CryoTreQHPS · Traditional | VitreQ BV | 12/30/2020SE |
| K940373 | Ophthalmic Cryo UnitHPS · Traditional | Dutch Ophthalmic USA, Inc. | 07/18/1994SE |
| K923629 | Ophthalmic Trichiasis ProbeHPS · Traditional | Mira, Inc. | 10/19/1992SE |
| K903303 | Spembly Medical 242 Cryounit/Series 242 CryoprobesHPS · Traditional | Spembly Medical , Ltd. | 10/11/1990SE |
| K874555 | Keeler Acu 22XT Ophthalmic Cryo UnitHPS · Traditional | Keeler Instruments, Inc. | 01/29/1988SE |
| K873388 | Keeler Ctu Cryo SystemHPS · Traditional | Keeler Instruments, Inc. | 11/13/1987SE |
| K870195 | United Surgical Corp. Cryoptic PlusHPS · Traditional | United Surgical Corp. | 02/20/1987SE |
| K833747 | Gallie CryonucleatorHPS · Traditional | Mono Research Laboratories | 05/09/1984SE |
| K801418 | Keeler Amoils Acull Cryo Ophthalmic UnitHPS · Traditional | Keeler Optical Products , Ltd. | 07/21/1980SE |
| K790102 | Model 556-01 CryoextractorHPS · Traditional | Intermedics, Inc. | 02/12/1979SE |
More from Intermedics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K915378 | Weck TrocarHET · Traditional | 06/29/1992SE |
| K914690 | LM15(TM), Catalog Number - 523821GCJ · Traditional | 03/23/1992SE |
| K911915 | Hemoclip IIFZP · Traditional | 01/09/1992SE |
| K914470 | Pneumo-Seal(Tm)GCJ · Traditional | 11/29/1991SE |
| K911272 | Endoscopic Needlholder Cat. Number 114705FHG · Traditional | 07/02/1991SE |
| K902108 | Hem-O-Lok(Tm)FZP · Traditional | 08/06/1990SE |
| K902232 | Weck Electrosurgical Generator #174200GEI · Traditional | 08/02/1990SE |
| K897045 | Bowie-Dick Test Card Catalog Number 008018JOJ · Traditional | 02/15/1990SE |
| K871110 | Coronary Artery Bypass Graft (Cabg) MarkerDSY · Traditional | 08/27/1987SE |
| K851251 | Auto/Manual Titanium Hemoclip Ligating Clip 527200FZP · Traditional | 07/02/1985SE |
Questions and answers
When was Beaver Cataract Cyroxtractor cleared by the FDA?
Beaver Cataract Cyroxtractor (K781338) received a 510(k) decision of Substantially Equivalent on February 12, 1979, 192 days after the submission was received.
What is the product code of K781338?
The FDA product code is HPS – Unit, Cryophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4170.