Precision - Cosmet Capsule Coupeur

FDA 510(k) K852934 · Precision-Cosmet Co., Inc.

Substantially Equivalent

510(k) numberK852934

Submission

Device name
Precision - Cosmet Capsule Coupeur
Applicant
Precision-Cosmet Co., Inc.
Minnetonka, MN, US
Received
July 9, 1985
Decision date
August 8, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HNY – Cystotome
Device class
Class I (low risk)
Regulation
21 CFR 886.4350
Specialty
Ophthalmic

Other 510(k)s with product code HNY

510(k)DeviceApplicantDecision
K961524Sterilab Cannulas, Sterilab Cystotmes, Sterilab Needles and Sterilab Lens ManipulatorsHNY · Traditional Sterilab, Inc.05/16/1996SE
K880345Cystotomes/KnifesHNY · Traditional Myocure, Inc.05/03/1988SE
K875001Prisma Disposable Blunt Irrigating CystotomeHNY · Traditional Advanced Surgical Products, Inc.04/13/1988SE
K874997Prisma Disposable Straight Irrigating CystotomeHNY · Traditional Advanced Surgical Products, Inc.04/13/1988SE
K874993Prisma Disposable Sharp Irrigating CystotomeHNY · Traditional Advanced Surgical Products, Inc.04/13/1988SE
K874983Prisma Disposable Angled Irrigating CystotomeHNY · Traditional Advanced Surgical Products, Inc.04/13/1988SE
K874976Prisma Dispos. Double Sharp Irrigating CystotomeHNY · Traditional Advanced Surgical Products, Inc.04/13/1988SE
K874975Prisma Disposable Sharp Angled Irrigat. CystotomeHNY · Traditional Advanced Surgical Products, Inc.04/13/1988SE
K873163Van Dellen Irrigating CystotomeHNY · Traditional Van Dellen, Ltd.09/04/1987SE
K871365Capsulectomer CystotomeHNY · Traditional Noetix, Inc.04/16/1987SE

More from Noetix, Inc.

510(k)DeviceDecision
K861057Manual Ophthalmic Surgical InstrumentsHNR · Traditional 04/24/1986SE
K840204White Ocular Pressure Relief DeviceKYF · Traditional 02/15/1985SE
K840104Petrus Iol GuideKYB · Traditional 04/24/1984SE

Questions and answers

When was Precision - Cosmet Capsule Coupeur cleared by the FDA?

Precision - Cosmet Capsule Coupeur (K852934) received a 510(k) decision of Substantially Equivalent on August 8, 1985, 30 days after the submission was received.

What is the product code of K852934?

The FDA product code is HNY – Cystotome, a Class I (low risk) device regulated under 21 CFR 886.4350.