Atlas FDA

FOAM TIP INJECTOR

FDA 510(k) clearance K980696 · decided 1998-09-11

Clearance details

K-number
K980696
Device name
FOAM TIP INJECTOR
Applicant
Staar Surgical Co.
Decision
Substantially Equivalent
Date received
1998-02-23
Decision date
1998-09-11
Days to decision
200 days
Clearance type
Traditional
Product code
MSS
Device class
1
Regulation number
886.4300
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Monrovia, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
MicroSTAAR Injector, MSI-PF Packed ten per box. recall (Z-0957-04)Staar Surgical Co Inc2004-07-20

PMA approvals by this applicant

RecordFirmDate
SILICON UV-ABSORBING POSTERIOR CHAMBER IOL (P880091/S032)Staar Surgical Co.2010-09-16
STAAR SURGICAL ELASTIC/ELASTIMIDE/ELASTIC TORIC/ASPHERIC ELASTIMIDE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR (P880091/S030)Staar Surgical Co.2009-02-13
STAAR SURGICAL ELASTIC/ELASTIMIDE/ELASTIC TORIC/ASPHERIC ELASTIMIDE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR (P880091/S029)Staar Surgical Co.2009-01-09
STAAR SURGICAL ELASTIC/ELASTIMIDE & ELASTIC TORIC ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (P880091/S028)Staar Surgical Co.2008-09-10
STAAR SURGICAL ELASTIC/ELASTIMIDE/ELASTIC TORIC ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (P880091/S027)Staar Surgical Co.2008-08-08
SILICONE UV ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P880091/S025)Staar Surgical Co.2008-07-29
STAAR SURGICAL SILICONE UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P880091/S026)Staar Surgical Co.2008-05-14
STAAR SURGICAL SILICONE UV - ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P880091/S024)Staar Surgical Co.2008-01-16