Atlas FDA

CYSTOTOME, 140-S

FDA 510(k) clearance K840475 · decided 1984-04-05

Clearance details

K-number
K840475
Device name
CYSTOTOME, 140-S
Applicant
Cilco, Inc.
Decision
Substantially Equivalent
Date received
1984-02-03
Decision date
1984-04-05
Days to decision
62 days
Clearance type
Traditional
Product code
HNY
Device class
1
Regulation number
886.4350
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Cilco

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS (K961524)Sterilab, Inc.1996-05-16
CYSTOTOMES/KNIFES (K880345)Myocure, Inc.1988-05-03
PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME (K874976)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME (K874993)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME (K875001)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOME (K874983)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME (K874997)Advanced Surgical Products, Inc.1988-04-13
PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME (K874975)Advanced Surgical Products, Inc.1988-04-13
VAN DELLEN IRRIGATING CYSTOTOME (K873163)Van Dellen, Ltd.1987-09-04
CAPSULECTOMER CYSTOTOME (K871365)Noetix, Inc.1987-04-16
LOOK IRRIGATING CYSTOTOMES (K870439)Look, Inc.1987-02-20
MECHANICAL CYSTITOME (K862709)Rudolph Beaver, Inc.1986-08-01

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING (P820016/S002)Cilco, Inc.1991-12-20