Atlas FDA

DISPOSABLE CYSTOTOME

FDA 510(k) clearance K831916 · decided 1983-07-12

Clearance details

K-number
K831916
Device name
DISPOSABLE CYSTOTOME
Applicant
CooperVision, Inc.
Decision
Substantially Equivalent
Date received
1983-06-14
Decision date
1983-07-12
Days to decision
28 days
Clearance type
Traditional
Product code
HNY
Device class
1
Regulation number
886.4350
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Southampton, GB
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
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
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S033)CooperVision, Inc.2025-12-23
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S032)CooperVision, Inc.2025-12-17
Biofinity XR Toric and Biofinity Toric Multifocal (Comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S193)CooperVision, Inc.2025-12-11
Sofmed® breathables™ XW NEXT (P080011/S191)CooperVision, Inc.2025-12-05
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S031)CooperVision, Inc.2025-10-28
Biofinity Toric Multifocal and Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S192)CooperVision, Inc.2025-09-22
up&up Monthly Performance + (P080011/S184)CooperVision, Inc.2025-08-20
iWear oxygen presbyopia (P080011/S186)CooperVision, Inc.2025-08-20