510(k) K862343
- Device
- Vacuum Handle Model I/a - 1
- Applicant
- CUTLER MEDICAL INSTRUMENTS
- 510(k) number
- K862343
- Product code
- HQE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-07-11
- Date received
- 1986-06-20
- Regulation
- 886.4150
- Classification name
- Instrument, Vitreous Aspiration And Cutting, Ac-Powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID P CUTLER
- Address
- 4607 Kenneth Ave. Santa Monica CA US 93455 93455
FDA Registration Numbers#
- 1932180
- 1722139
- 3015456951
- 3019924
- 3003398873
- 1047843
- 2935428
- 1526711
- 9681121
- 3009039068
- 9615010
- 1932402
- 1928237
- 8030967
- 1920664
- 1644019
- 3002907620
- 3002807090
- 2523835
- 2028523
- 9611516
- 2028159
- 1650907
- 2246552
- 3005941719
- 3010208880
- 2529392
- 3007648309
- 1313525
- 3042928348
- 3010220595
- 3009337401
- 3006946276
- 3010291427
- 2953359
- 3005012805
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HQE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K212763 | UniVit HE, UniVit UHS | Visioncare Devices, LLC | 2022-08-10 |
| K170183 | Cetus system, Cetus probe | A.R.C Laser GmbH | 2017-09-27 |
| K153168 | Bi-Blade Vitrectomy Cutter | Medical Instrument Development Laboratories | 2016-04-29 |
| K141065 | CONSTELLATION VISION SYSTEM | Alcon Research, Ltd. | 2014-08-22 |
| K121675 | VERSAVIT | Synergetics, Inc. | 2012-06-21 |
| K120170 | PROCARE PLUS VITRECTOMY SYSTEM | Visioncare Devices, Inc. | 2012-05-30 |
| K102222 | ULTIMATE VIT ENHAMCER (UVE) | Medical Instrument Development Laboratories, Inc. | 2011-04-08 |
| K033390 | COLIBRI DISPOSABLE VITRECTOMY CUTTER | Microworld Medical Instruments, Inc. | 2003-11-04 |
| K030948 | VMATE MODEL VMM1000 | Howard Instruments, Inc. | 2003-06-17 |
| K023939 | VELOCITY ADVANTAGE | Visioncare Devices, Inc. | 2003-04-17 |
| K020911 | MID LABS AUTONOMOUS VIT ENHANCER (AVE) | Medical Instrument Development Laboratories, Inc. | 2002-04-29 |
| K010082 | D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM | Dutch Ophthalmic USA, Inc. | 2001-03-12 |
| K992943 | VIT ENHANCER | Medical Instrument Development Laboratories, Inc. | 1999-12-10 |
| K990292 | I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN | Ophthalmic Consultants, Inc. | 1999-11-19 |
| K983797 | D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM | Dutch Ophthalmic USA, Inc. | 1999-03-03 |