FDA 510(k)

COOPERSURGICAL MALLEABLE SYTLET

K-Number: K023382 · 2002-12-20

Decision Date2002-12-20

Product CodeMQF

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

COOPERSURGICAL MALLEABLE SYTLET is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Surgical. It received FDA 510(k) clearance on 2002-12-20 under 510(k) number K023382. The device is classified under product code MQF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOPERSURGICAL MALLEABLE SYTLET?

COOPERSURGICAL MALLEABLE SYTLET is a medical device that received FDA 510(k) clearance on 2002-12-20. The listed applicant is Cooper Surgical. The 510(k) number is K023382.

When did COOPERSURGICAL MALLEABLE SYTLET receive FDA 510(k) clearance?

COOPERSURGICAL MALLEABLE SYTLET received FDA 510(k) clearance on 2002-12-20, under 510(k) number K023382.

Who is the listed applicant for COOPERSURGICAL MALLEABLE SYTLET?

The FDA 510(k) record lists Cooper Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COOPERSURGICAL MALLEABLE SYTLET?

The FDA product code for COOPERSURGICAL MALLEABLE SYTLET is MQF.

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Other records listing Cooper Surgical as applicant

K253698Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes K091325TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS K023384COOPERSURGICAL TRIAL TRANSFER CATHETER K023383COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER K023379COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER

Related Devices (Code: MQF)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.