FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE IRRIGATING/ASPIRATING HANDPIECE
K Number: K910973
·
Decision Apr 26, 1991
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
148
Applicant Total
28
Review Days
50
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DISPOSABLE IRRIGATING/ASPIRATING HANDPIECE
- K Number
- K910973
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Surgical Technologies, Inc.
- Date Received
- March 7, 1991
- Decision Date
- April 26, 1991
- Product Code
- HQE
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HQE), ordered by most recent decision date.
UniVit HE, UniVit UHS
FDA 510(k)
FDA Class 2
·Ophthalmic
Cetus system, Cetus probe
FDA 510(k)
FDA Class 2
·Ophthalmic
Bi-Blade Vitrectomy Cutter
FDA 510(k)
FDA Class 2
·Ophthalmic
CONSTELLATION VISION SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
VERSAVIT
FDA 510(k)
FDA Class 2
·Ophthalmic
PROCARE PLUS VITRECTOMY SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
Other Clearances by Surgical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941992 | CYSTOSCOPE | Nov 30, 1995 | Substantially Equivalent |
| K942029 | ARTHROSCOPE | Nov 8, 1995 | Substantially Equivalent |
| K946136 | INFINITECH LIGHTED INFUSION CANNULA | Oct 2, 1995 | Substantially Equivalent |
| K952566 | OSCILFLATOR | Aug 31, 1995 | Substantially Equivalent |
| K951918 | SURGICAL TECHNOLOGIES, INC. SYRINGE | Jul 20, 1995 | Substantially Equivalent |
| K950683 | ARTHROGRAM TRAY | May 6, 1995 | Substantially Equivalent |
| K946135 | INFINITECH ASPIRATING LASER PROBE | Apr 18, 1995 | Substantially Equivalent |
| K946181 | INFINITECH SOFT TIP FLUTE NEEDLE | Mar 14, 1995 | Substantially Equivalent |
| K942030 | BIOPSY SCISSORS | Jun 27, 1994 | Substantially Equivalent |
| K942482 | PRESSURE MONITORING EXTENSION | Jun 14, 1994 | Substantially Equivalent |