Atlas FDA

SILASTIC SCLERAL SPONGE II W/CIRCLING BD

FDA 510(k) clearance K800140 · decided 1980-03-03

Clearance details

K-number
K800140
Device name
SILASTIC SCLERAL SPONGE II W/CIRCLING BD
Applicant
Dow Corning Corp. Healthcare Industries Materials
Decision
Substantially Equivalent
Date received
1980-01-21
Decision date
1980-03-03
Days to decision
42 days
Clearance type
Traditional
Product code
HQX
Device class
2
Regulation number
886.3340
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
MICROVISION SCLERAL BUCKLING COMPONENTS (K023481)Microvision, Inc.2003-01-08
OCU-GUARD AND OCU-GUARD SUPPLE (K983581)Bio-Vascular, Inc.1998-11-06
RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES (K980816)Fci Ophthalmics, Inc.1998-09-18
RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES (K963219)Fci Ophthalmics, Inc.1996-10-28
SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS (K950806)Mira, Inc.1996-06-05
STORS SCLERAL SPONGE II (LINCOFF DESIGN) (K950599)Storz Ophthalmics, Inc.1995-03-02
VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS (K945172)Visitec Co.1995-01-17
TAMCENAN OCULAR EXPLANTS AND BANDS (K902308)Tamcenan Corp.1990-06-19
O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES (K901002)Oculo Plastik, Inc.1990-05-22
PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL (K900929)Oculo Plastik, Inc.1990-05-18
COX MALAR EMINENCE IMPLANTS (K900928)Oculo Plastik, Inc.1990-05-15
CODERE-DURETTE ORBITAL FLOOR IMPLANT (K900927)Oculo Plastik, Inc.1990-05-15

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
THE SOFT RINSE SYSTEM (P800060/S007)Dow Corning Corp. Healthcare Industries Materials1991-03-05
SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S010)Dow Corning Corp. Healthcare Industries Materials1985-11-18
SILSOFT (ELASTOFILCON A ) CONTACT LENS (P800020/S007)Dow Corning Corp. Healthcare Industries Materials1985-11-05
THE SOFT RINSE SYSTEM (P800060/S006)Dow Corning Corp. Healthcare Industries Materials1985-07-30
SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S008)Dow Corning Corp. Healthcare Industries Materials1984-10-31
THE SOFT RINSE SYSTEM (P800060/S005)Dow Corning Corp. Healthcare Industries Materials1984-04-04
SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S009)Dow Corning Corp. Healthcare Industries Materials1984-03-12
SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S004)Dow Corning Corp. Healthcare Industries Materials1983-11-09