SpermSelect Curve Kit

FDA UDI

Class II (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name: SpermSelect Curve Kit FDA UDI
Generic Name: Spermatozoa/semen motility medium supplement FDA UDI
Device Name: Contents: One SpermSelect System and one TheCurve FDA UDI
Model / Reference: SM603-F FDA UDI
Description: Contents: One SpermSelect System and one TheCurve FDA UDI

Identifiers

Primary DI / UDI-DI: 60888937003644 FDA UDI
510(k) Number: K012935 FDA UDI
FDA Product Code: MFD FDA UDI
GMDN Term: Spermatozoa/semen motility medium supplement FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.5250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Spermatozoa/semen motility medium supplement

SpermSelect Curve Kit by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spermatozoa/semen motility medium supplement.

Enhance Sperm Wash with Gentamicin — Vitrolife AB · Class II
Enhance-S Plus — Vitrolife AB · Class II
Nidacon — Nidacon International AB · Class II
Nidacon — Nidacon International AB · Class II
Enhance-S Plus — Vitrolife AB · Class II
Nidacon — Nidacon International AB · Class II
Enhance Sperm Wash w/ Gentamicin — Vitrolife AB · Class II
Nidacon — Nidacon International AB · Class I

Cleared under the same submission

K012935 also covers:

TheCurve — CooperSurgical, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: CooperSurgical, Inc.

Sources (1)

FDA UDI a75db9e2-e6ce-480b-bd6a-29d78ba48b79 34 fields · synced Jun 9, 2026