FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERILE/SINGLE USE OPHTHALMIC CONFORMERS
K Number: K921229
·
Decision Jun 9, 1992
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
6
Applicant Total
101
Review Days
88
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
- STERILE/SINGLE USE OPHTHALMIC CONFORMERS
- K Number
- K921229
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.3130
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Storz Instrument Co.
- Date Received
- March 13, 1992
- Decision Date
- June 9, 1992
- Product Code
- HQN
- 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 |
|---|---|---|---|
| HQN | Conformer, Ophthalmic | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HQN), ordered by most recent decision date.
MEDPOR OCULAR CONFORMER
FDA 510(k)
FDA Class 2
·Ophthalmic
OCULAR CONFORMER
FDA 510(k)
FDA Class 2
·Ophthalmic
OCULAR CONFORMER
FDA 510(k)
FDA Class 2
·Ophthalmic
KOLBERG OPHTHALMIC CONFORMER
FDA 510(k)
FDA Class 2
·Ophthalmic
STERILE/SINGLE USE SYMBLEPHARON RING
FDA 510(k)
FDA Class 2
·Ophthalmic
MOLDEYE
FDA 510(k)
FDA Class 2
·Ophthalmic
Other Clearances by Storz Instrument Co.
| K Number | Device Name | ||
|---|---|---|---|
| K980100 | STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK | Jun 1, 1998 | Substantially Equivalent |
| K980488 | STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM | Mar 23, 1998 | Substantially Equivalent |
| K972664 | STORZ MILLENNIUM VISCOUS FLUID SYSTEM | Oct 10, 1997 | Substantially Equivalent |
| K971439 | STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES | Jun 17, 1997 | Substantially Equivalent |
| K964743 | STORZ E8010 ERGOTEC/PREMIERE ADAPTOR | Feb 3, 1997 | Substantially Equivalent |
| K960024 | STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH | Sep 20, 1996 | Substantially Equivalent |
| K960061 | STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE | Sep 18, 1996 | Substantially Equivalent |
| K960003 | STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION | Aug 29, 1996 | Substantially Equivalent |
| K962131 | STORZ D4600 AIR EXCHANGE LINE PACK | Aug 23, 1996 | Substantially Equivalent |
| K961831 | STORZ DP5200 IRRIGATION ADDMINISTRATION SET PACK | Aug 6, 1996 | Substantially Equivalent |