FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)
K Number: K863989
·
Decision Oct 31, 1986
Classifications
1
FEI Numbers
190
Registration Numbers
190
Same Product Code
10
Applicant Total
60
Review Days
17
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
- THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)
- K Number
- K863989
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Keeler Instruments, Inc.
- Date Received
- October 14, 1986
- Decision Date
- October 31, 1986
- Product Code
- HNC
- 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 |
|---|---|---|---|
| HNC | Specula, Ophthalmic | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HNC), ordered by most recent decision date.
STEPHENS DISPOSABLE SPECULUM
FDA 510(k)
FDA Class 1
·Ophthalmic
OCULOSTAT
FDA 510(k)
FDA Class 1
·Ophthalmic
EYE FIXATION SPECULUM
FDA 510(k)
FDA Class 1
·Ophthalmic
OPHTHALMIC SURGICAL SPECULUM
FDA 510(k)
FDA Class 1
·Ophthalmic
VISITEC EYE SPECULUM
FDA 510(k)
FDA Class 1
·Ophthalmic
EYELID SPECULUM
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Keeler Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K181143 | Keeler TonoCare Tonometer | Feb 8, 2019 | Substantially Equivalent |
| K112093 | CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER | Dec 8, 2011 | Substantially Equivalent |
| K093298 | PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 | Dec 10, 2010 | Substantially Equivalent |
| K100500 | PSL CLASSIC SLIT LAMP | Mar 9, 2010 | Substantially Equivalent |
| K062412 | CRYOMATIC | Nov 6, 2006 | Substantially Equivalent |
| K060822 | VANTAGE INDIRECT OPHTHALMOSCOPE | May 23, 2006 | Substantially Equivalent |
| K032087 | KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 | Nov 26, 2003 | Substantially Equivalent |
| K992954 | KEELER CRYO MASTER & PROBES | Dec 21, 1999 | Substantially Equivalent |
| K990257 | KEELER PULSAIR 3000 NON CONTACT TONOMETER | Mar 25, 1999 | Substantially Equivalent |
| K973064 | KEELER TEARSCOPE-PLUS | Apr 7, 1998 | Substantially Equivalent |