FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KOI LACREMAL HOOK & DILATOR
K Number: K812097
·
Decision Aug 18, 1981
Classifications
1
FEI Numbers
135
Registration Numbers
136
Same Product Code
2
Applicant Total
7
Review Days
25
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Basic Information
- Device Name
- KOI LACREMAL HOOK & DILATOR
- K Number
- K812097
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Koi, Inc.
- Date Received
- July 24, 1981
- Decision Date
- August 18, 1981
- Product Code
- HNW
- 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 |
|---|---|---|---|
| HNW | Dilator, Lachrymal | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HNW), ordered by most recent decision date.
INTER-SHARP
FDA 510(k)
FDA Class 1
·Ophthalmic
LACHRYMAL PROBES-VARIOUS
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Koi, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K843247 | KOI PACHYMETER | Apr 30, 1986 | Substantially Equivalent |
| K830366 | DIAMOND KNIFE | Mar 9, 1983 | Substantially Equivalent |
| K812764 | KOI BLUE FIELD ENTOPTOSCOPE | Dec 2, 1981 | Substantially Equivalent |
| K812450 | KOI DIAMOND KNIFE | Sep 21, 1981 | Substantially Equivalent |
| K812011 | BLADE GAUGE | Jul 28, 1981 | Substantially Equivalent |
| K812010 | KOI LACRIMAL INTUBATION SYSTEM | Jul 28, 1981 | Substantially Equivalent |